OpenClinica 3.0 is Here

New Features

• New Navigation
• Study Build Module
• Improved Performance of the Subject Matrix
• Source Data Verification
• Event Definitions Defined at the Site Level
• Extracting Data from CRFs not Marked Complete
• New Home Pages for Different Users

For more information https://www.openclinica.org/dokuwiki/doku.php?id=ocfeatures:openclinica3.0

OpenClinica

OpenClinica is a free, open source clinical trial software platform for Electronic Data Capture (EDC) clinical data management in clinical research. The software is web-based and designed to support all types of clinical studies in diverse research settings. From the ground up, OpenClinica is built on leading, independent standards to achieve high levels of interoperability and regulatory compliance. Its modular architecture and transparent, collaborative development model offer outstanding flexibility while supporting a robust, enterprise class, regulatory compliant, solution.

The OpenClinica software platform supports:

• Management of numerous, diverse clinical studies through a unified interface
• Clinical data submission, validation, and annotation
• Data filtering and extraction
• Study oversight, auditing, and reporting

Within these areas, OpenClinica has a large and growing number of features.

OpenClinica is released under the LGPL open source license. The product is commercially supported by Akaza Research to facilitate enterprise-level use.

You can downlload free software at http://www.openclinica.org/

Please contact incase you face any kind of problem during installing.

Some Indian CRO's

Hi,
I am posting list of Indian CRO's which I got from various forums and blogs. Hope i will be helpfull to all.

Merck
http://www.merck.co.in/en/careers/india/merck_in_india/merck_in_india.html

Covance
http://www.covancecareers.com/searchJobs.php

Wipro life sciences (it's for cdm i guess )
http://www.wipro.com/industries/pharmaceutical-bio-tech/solutions/clinical-data-management.htm

Abott India
http://www.abbott.co.in/

PFC pharma
http://www.pfc.ch/pages/index.cfm?

Bilcare
http://www.bilcare.com/about_us/careers.htm

Ipca
http://www.ipcalabs.com/

Reliance Life Sciences
http://www.rellife.com/

i3
http://www.i3global.com/Businesses/i3Research/

APEX International Clinical Research Co., Ltd.
http://www.apex-cro.com/

Actimus Biosciences Pvt. Ltd. Visakhapatnam
http://www.actimusbio.com/

Asian Clinical Trials .
http://www.act-india.com/

Astrom Research International
http://www.astromresearch.com/

BioArc Research Solutions, Division of Alembic Ltd. India
http://www.bioarcresearch.com/

Ace Biomed
http://www.acebiomed.com/

Catalyst Clinical Services -
http://www.catalystclinicalservices.com/

Chembiotek - CRO in India .
http://www.chembiotek.com/

Chembiotek - CRO in India –
http://www.chembiotek.com/

ClinArt International -
http://www.clinart.net/

ClinInvent Reserach Pvt Ltd -
http://www.clininvent.com/

ClinTech Research India Pvt. Ltd –
http://www.clintechresearch.com/

CliniReach
http://www.clinireach.in/

Clinigene - India - Clinigene International Limited is a full-service Clinical Research Organization
http://www.clinigeneintl.com/

Asian Clinical Trials
http://www.asiaticlinical.com

Cliniminds
http://www.cliniminds.com/

Clintrac International Pvt Ltd - A contract research organisation based in Bangalore India.
http://www.clintracintl.com/

Cqua Research International Inc - Full services clinical trial management group, 200 clinical sites in India, canada and onership to many research sites and a Phase I facility in India
http://www.cquaint.com/

D2L-SMO - Site management services - D2L-SMO is a professionally driven “Multi-site, Multi-specialty SMO” for cost effective and efficient clinical trial execution. Headquartered in Bangalore, India, we offer site management expertise services to Pharmaceutical Companies & CROs
http://www.d2lpharma.com/

DIL Limited - DIL Limited (formely Duphar-Interfran Ltd) A Dynamic- Intelligent- Lively Organization located in Thane (India) provides customised research solutions.
http://www.dil.net/

Excel life Sciences, inc. - US based India focused clinical research solution provider. Special emphasis on PI, site identification and total study conduct.
http://www.excellifesciences.com/

Fermish Clinical Technologies Pvt. Ltd. India - Fermish Clinical Technologies Pvt. Ltd. India provides complementary services for clinical research and Pharmaceutical Regulatory Services.
http://www.fermish.com/

Genomics/Proteomics Research & Consulting Services - Siri provides on-site and offshore services including data curation services, work on expensive technologies in your drug design. Based out of Bangalore, India, Siri has abundant scientific resources and software tools that our clients can make use of
http://www.siritech.com/life.htm

Gleneagles CRC - A Pan-Asian Site Management Organization (SMO)and Contract Research Organization (CRO) headquartered in Singapore. Includes a clinical research network of over 40 sites located in Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines, Mainland China, Hong Kong, Taiwan, India, Australia and New Zealand.
http://www.gleneaglescrc.com/

Gleneagles CRC - A Pan-Asian Site Management Organization (SMO)and Contract Research Organization (CRO) headquartered in Singapore. Includes a clinical research network of over 40 sites located in Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines, Mainland China, Hong Kong, Taiwan, India, Australia and New Zealand.
http://www.gleneaglescrc.com/

Global Clinical Trials & Research Organization - GCTRO is a USA based CRO specializing in doing Clinical Trials in India for US and Canadian Sponsors
http://www.gctro.com/

Global Pharmatech - Contract manufacturing of a wide range of pharmaceutical formulations for human as well as veterinary applications (India).
http://www.globalpharmatech.com/

INTOX PVT. LTD. - INTOX is a toxicological CRO located in Pune, near Mumbai in India, and conducts toxicity studies on pharmaceuticals, agrochemicals and biologicals
http://www.intoxlab.com/

Integrity Medical Group, Inc. - Integrity Medical Group offers full range of contract research services to the Pharmaceutical, Biotech, and Medical Devices Industry through established global professional network with utmost "INTEGRITY".
http://www.imedgrp.com/

Jinsite-Largest China Biology CRO! - Jinsite is CRO?providing biology outsourcing services. As a China-based CRO, we offer our partners in the pharmaceutical industry and research institutes with a cost effective solution to high quality assay development and drug discovery services.
http://www.jinsite.com.cn/en/

Kuantum-CRO - Based in Izmir, Turkey, Kuantum offers its clients a broad range of clinical research services, specialing in Phase III and IV studies conducted in Turkey.
http://www.kuantum-cro.com/index.html

Maccine - Preclinical CRO based in Singapore - Innovative in vivo discovery support and quality safety assessment is offered through state-of-the-art AAALAC accredited and FDA GLP compliant laboratories.
http://www.maccine.com/

Materiamedica Services Pvt. Ltd. - MMSPL is a Contract research Organization operating from Mumbai India since 1996. Multinational Clinical trials and healthcare functions.
http://www.dagaonkar.com/

Materiamedica Services Pvt. Ltd. - MMSPL is a Contract research Organization operating from Mumbai India since 1996. Multinational Clinical trials and healthcare functions.
http://www.dagaonkar.com/

Medical and Clinical Writing - Medical Writing Online provides Writing Services for Case Report Forms, Protocol Writing, Medical Research Report Writing, Standard Operating Procedures, Clinical Trial Randomization Writing
http://www.medicalwritingonline.com/

Metrics Research - Metrics Research is the first Multinational Clinical Research and Site Management Organization (CRO/SMO) of Pakistan. It caters to clinical research and development programs of the pharmaceutical, biotechnology and medical device industries.
http://www.mrcro.com/

Monitor Medical Research and Consulting - International CRO services based in Istanbul, Turkey.
http://www.monitorcro.com/

NanoBioServices - NanoBioServices is a Contract Research Organization which provides quality service to Pharmaceutical, Biotechnology, Agriculture nas Nanotechnology companies worldwide by offering cost effective, time bound services for Biotechnology , Pharmaceutical R&D
http://www.nanobioservices.com/

Neeman Medical International (NMI) - Neeman Medical International (NMI) is an international Contract research Organisation in india.
http://www.neeman-medical.com/

Neptun Contract Research Organization (CRO) - NEPTUN-CRO is a full-service contract research organization (CRO) located in Istanbul, Turkey. NEPTUN-CRO performs quality clinical, and epidemiological research management to multinational pharmaceutical companies, medical and other health organizations.
http://neptun-cro.com/

PLS: Contract / Clinical research organization (CRO) specializing in clinical trials in India for US customers - Contract Clinical Research Organization (CRO), provides clinical trial management, data management, site managment, clinical trial monitoring, medical consulting, regulatory consulting, medical writing, in India.
http://www.progressivelifesciences.com/

PharmAffiliates Analytics & Synthetics (P) Ltd - An integrated CRO located in Asia headed by Mr.A.K.Sabharwal offering custom synthesis, method validation, development & testing, impurity synthesis & profiling, stability-storage & testing with state-of-the art research facilities.
http://www.pharmaffiliates.com/

Preclinical Contract Research Organization - Jai Research Foundation - A GLP compliant Preclinical CRO and Safety Assessment Laboratory
http://www.jrfonline.com/

Premas Biotech PVT LTD - PREMAS Biotech's three main operational activities/functions are Contract Research Services, Consultancy, Business Development in Life sciences.
http://www.premasbiotech.com/

Protech Pharmaservices Corporation (PPC) - A Taipei-headquartered CRO providing ICH-GCP compliant clinical trial management(Phase I-IV), bioequivalence and pharmacoeconomic studies, botanical drug R&D and central laboratory services.
http://www.ppccro.com/

Quartesian LLC - A Global Full Service CRO - We provide state of the art cost effective clinical development services to pharmaceutical, biotechnology and medical device companies.
http://www.quartesian.com/

RDDT Laboratories - RDDT is an OECD GLP compliant preclinical CRO and bioanalytical facility based in Australia. RDDT offers a range of preclinical services. RDDT has experience in the following: * Preclinical toxicology * Discovery * Bioanalytical * Genotoxicity
http://www.rddt.com.au/

Rejuvendus Clinical Research Ptv. Ltd. - A full-service CRO dedicated to providing clinical trials management and support to pharmaceutical companies for Phase I – IV clinical trials.
http://www.rejuvendus.com/

Research Support International Ltd - Incorporated in 2004, Research Support International Limited ('RSIL') is a 100% subsidiary of DIL Ltd. (formerly Duphar-Interfran Ltd.) providing Contract Research & Custom Synthesis
http://www.rsil.biz/

SMO-India, India's leading provider of Site Management Services - with a team of experienced professionals who are highly process-driven in performing global clinical trials.
http://www.smo-india.com/

Siro ClinPharm Pvt Ltd - Full service CRO based in India works with pharmaceutical companies to conduct clinical trials in various therapeutic areas
http://www.siroindia.com/

Synchron Research Services Pvt. Ltd. - Indian CRO Provides a broad range of Phase I clinical research services including bioavailability, bioequivalence and pharmacokinetic studies in their new clinical research unit.
http://synchronresearch.com/

TCG Lifesciences Ltd. - A leading life sciences contract research and informatics solutions organization focused on enabling Translational Medicine. Expertise areas - Discovery Research, Clinical Research & Development and Enterprise Informatics.
http://www.tcgls.com/

Total Quality Management Consultants - Consultancy and Training for all management systems and Clinical Research Organizations
http://tqmc.org/

Vedic Lifesciences - Vedic is an India base CRO, specialized in carrying our pre clinical as well as clinical trials on Pharmaceutical, Nutraceutical & Natural products.
http://www.vediclifesciences.com/

Virginia Contract Research Organization Co., Ltd. (VCRO) - VCRO is the leading CRO based in Taiwan since 1997 providing ICH-standard clinical trial and BA/BE/PK study services. Currently, VCRO is the only Taiwan-based CRO with 100% ICH-GCP inspection record.
http://www.vcro.com.tw/

iGATE Clinical Research - iGATE Clinical Research International is a contract research organization offering a complete range of clinical trials support services for conducting Phase II-IV clinical trials in India.
http://www.igate.com/icri/

Accutest Research Laboratories
A-31, TTC Industrial area,
Khairane MIDC, Thane,
Belapur Road, Navi Mumbai
Maharashtra 400 709
http://www.accutestindia.com/ser_clinicaltrials.asp

Ace Biomed
Indian Cork Mill Compound,
Saki Vihar Road, Powai, Mumbai
Maharashtra 400 072
http://www.acebiomed.com/

Actimus Biosciences
4th floor, Varun Towers,
Kasturba Marg, Siripuram, Visakhapatnam
Andhra Pradesh 530 003
Apothecaries
579 Devli East Sainik Farms,
New Delhi 110 062
http://www.apothecaries.net/

Dr Lal PathLabs Pvt Ltd
Eskay House, 54, Hanuman Road,
New Delhi Delhi 110 001
phone: 23366569/23342046
web: www.lalpathlabs.com

GVK Biosciences Pvt Ltd
#210, My Home Tycoon, 6-3-1192,
Kundanbagh Begumpet, Hyderabad
Andhra Pradesh 500 016
P hone: 5551990
Fax: 55626885
http://www.gvkbio.com/

iGate Clinical Research International
101/102, Alpha, Hiranandani Gardens, Powai,
Mumbai, Maharashtra 400 076
www.igatecorp.com/icri/

INTOX Private
375, Urawade,
Pirangut Taluka Mulshi District - Pune
Maharashtra 412 108
http://www.intoxlab.com/

Jubilant Clinsys
c-46, Sector 62,
Noida, UP 201 301
http://www.jubl.com/

Kendle India
23-24, Vatika Business Center,
2nd floor, First India Place,
Block B, Mehrauli-Gurgaon Road,
Sushant Lok-1 Gurgaon, UP 122 002
http://www.kendle.com/

Lambda Therapeutic Research Ltd
42 Premier House 1,
Bodakdev Sarkhej Gandhinagar Highway,
Ahmedabad, Gujurat 380 054
Phone: 26853995/3441/
Fax: 26840079
http://www.lambda-cro.com/

Lotus Labs
NO.15, 80ft Rpad,
Bangalore, Karnataka 560 095
http://www.lotuslabs.com/

Manipal Acunova
Manipal towers 14,
Airport Road, Bangalore,
Karnataka 560 100
http://www.acunovalife.com/

Medpace
502, Sentinel, Hiranandani Gardens, Powai
Mumbai 400076
http://www.medpace.com/

Metropolis Clinical Laboratories
Plot No.250D, Udyog Bhavan,
Hindi Cycle Marg, Worli
Mumbai, Maharashtra 400 030
http://www.metropolisindia.com/

Omnicare Clinical Research India
#208 Midford House, Midford Garden Road,
Off M G Road, Bangalore, Karnataka 560 001
http://www.omnicarecr.com/

PPD Pharmaceutical Development India
406 Acropolis, Military Road,
Marol Andheri (E), Mumbai,
Maharashtra 400 059
http://www.ppdi.com/

Quintiles Spectral Private
3 Ashoknagar Bungalows,
Ahmedabad, Gujurat 380 015
www.quintiles.com/india

Reliance Clinical Research Services
DAKC-LSC, R-282, TTC Areas of MIDC,
Thane Belapur road Rabale, Navi Mumbai,
Maharashtra 400 701
http://www.relclin.com/

Sipra Labs Pvt Ltd
407, Nilgiri, Aditya Enclave Ameerpet,
Hyderabad, Andhra Pradesh 500 038
Phone: 23734720/23746873
Fax: 23746871
http://www.sipralabs.com/

Sitec Labs
Building No.14, 2nd floor,
CTS No.82, Village Hariyaly,
LBS Marg, Vikhroli (W)
Mumbai, Maharashtra 400 083

SRL Ranbaxy Clinical Reference Laboratories
113, MIDC, 15th Street Andheri (E)
Mumbai, Maharashtra 400 093
Phone: 56903851-61
Fax: 56924717
http://www.srlranbaxy.com/

Statkon
1201 Panchmahal,
Panchshrishti Complex, Hiranandani Gardens,
Powai, Mumbai, Maharashtra 400076
Sterling Synergy Systems
Nirlon House, 1st floor,
254B,Dr. Annie Besant Road,
Worli, Mumbai,
Maharashtra 400 045
http://www.sterling-synergy.com/

Vimta Labs
142, IDA, Phase II Cherlapally,
Hyderabad, Andhra Pradesh 500 051
Phone: 27264141
Fax: 27263657
http://www.vimta.com/

Wellquest
Wellspring Hospital (6th floor),
Ganpatrao Kadam Marg, Off Worli Naka,
Lower Parel, Mumbai,
Maharashtra 400 013
http://www.nicholaspiramal.com/

Roxaane Research Private Limited
Ascendas IT Tech Park,
Phase II , 13th Floor,
CSIR Road, Taramani,
Chennai - 600 113,
Tamil Nadu,
Phone : +91 44 4291 2900
Email: info@roxaane.com

Icon
Progressive Life Sciences
903, Arunachal building,Barakhamba Road, New Delhi.
Fax- +91-11-23321509, (623) 433-1980
Phone: +91-9968295224
http://www.iconclinical.com/

FERMISH CLINICAL TECHNOLOGIES PVT. LTD.
D - 115, Okhla Industrial Area, Phase - I, New Delhi - 110020, India
Tel : +91 11 3088 5160
Fax : +91 11 3088 5169
Mail : contact@fermish.com
http://fermish.com/index.htm

VIBGYOR Scientific Research
Head Office:
45, World Business House,
Near Parimal Garden,
Ellisbridge.Ahmedabad - 380006
Gujarat, India
Phone : +91-79-26565076
Fax : +91-79-26563942
Email : info@vibgyorcare.com

Veeda Clinical Research - India
Shivalik Plaza-A, Near IIM
Ambawadi
Ahmedabad- 380 015
India
Tel: +91 79 3001 3000
Fax: +91 79 3001 3010
E-mail: info@veedacr.com
http://www.veedacr.com/

PharmaNet Clinical Services Private Ltd.
Bangalore, INDIA
Unit 1101, Level 11
Millenia Tower B
12 Murphy Road
Ulsoor, Bangalore 560 008
http://www.pharmanet.com/index.html

Chiltern
http://www3.chiltern.com/index.php

Klintra Research and Technology Services Ltd,
5A/320, Shanthi Nagar, OMR, Kandanchavadi,
Chennai-600096
Apothecaries Limited
579, Devli, East of sainik Farm
New Delhi
http://www.apothecaries.net/

Fortis Clinical Research Ltd. (FCRL)
Sunflag Hospital & Research Center,
Sector 16-A, Faridabad 121 002 (Haryana)
India
Phone : +91-129-4090-900
E-mail: contact@fortis-cro.com
kavita.singh@fortis-cro.com

Huclin Research Ltd,
TICEL Biopark, Taramani
Chennai, TN, India
Phone : +91-44-22540200
Tel/Fax: +91-44-22540211
http://www.huclin.in/

Pharma Intel Drug Research & Consultancy Group
377 Purbalok
Kolkata 700099
Phone/Fax:+91-33-2426 7481
Email: info@pharmaintel.com
http://www.pharmaintel.com/

AZIDUS LABORATORIES LTD
23, School Road, Rathnamangalam, Vandalur
Chennai, India
E-mail: info@azidus.com
http://www.azidus.com/

MakroCare Clinical Research Organization Ltd.,
#1-65/2/256,Makro Towers,
Kavuri Hills,Madhapur,HYDERABAD-500 033.
http://www.makrocare.com/

SPECTRUM CLINICAL RESEARCH
401 Kshamalaya,
37 New Marine Lines,
Mumbai 400 020,
India
Tel. : +91-22-6615 5570 / 4064 5100
Fax. : +91-022– 6615 5567
Email: info@spectrumcr.com
http://www.spectrumcr.com/

Astron Research
10th Floor, Premier House, Opp. Gurudwara,
Sarkhej-Gandhinagar Highway, Bodakdev,
Ahmedabad - 380054, Gujarat, India
Tel.: +91-79-2685 3518

Pharma - Olam International
217, 4th Cross, 19th Main
Koramangala 6th Block, Banglore - 95
phone : 080- 56984164
Email : info@pharm-olam.com,
http://www.pharm-olam.com/

Matrix laboratories limited
1-1-11/1, 4th Floor, Sai Ram Towers
Alexander Road, Secunderabad - 500003
Ph: 91-40-27700363, 55327722 Fax : 27700343
Email : matrix@matrixlabsindia.com
http://www.matrixlabsindia.com/

INTOX Private
375, Urawade, Pirangut Taluda Mulshi
District - Pune, 412108
Email : intox@vsnl.com
http://www.intoxlab.com/

Sristek
Plot No: 33, Sai Enclave,Road No.: 12, Banjara Hills
Hyderabad 500 034
T: +91-40-66743111
Fax: +91-40-66683777
E-mail: sristek@sristek.com
http://www.sristek.com/

Criterium India
Plot No 69, Survey No 98,
Ground Floor,Bhusari Colony,
Paud Road, Pune 411038, Maharastra, India
Phone: +91 20 25285884
Fax: +91 20 25284211

Kendle International (New Office, 2nd in India)
B wing, 9th floor,
Safal Pegasus, Nr. Prahaladnagar Garden
Anandnagar,
Ahmedabad -380015
Tel: +91 124 453 6300
Email: doshi.bharat@kendle.com

Quinlan Lifesciences India (QLS)
Goa- 403001.
http://www.quinlanlifesciences.com/
contact@quinlanlifesciences.com

Sanofi Aventis
http://www.aventispharmaindia.com/

GSK
http://www.gsk-india.com/

Novartis
http://www.novartis.com/

TCS
http://www.tcs.com/homepage/Pages/default.aspx

Accenture
http://www.accenture.com/

Bristol Myers Squibb
http://www.bms.com/pages/default.aspx

Roche
http://careers.roche.com/india

Astrazeneca (India)
http://www.astrazenecaindia.com/

Novartis
http://www.novartis.com/

Indegene
http://www.indegene.com/html/home.html

Healthcare industry grew 42 percent in first quarter

NEW DELHI: India's healthcare industry registered 42.44 percent growth in net profit during April-June, according to the Associated Chambers of Commerce and Industry (Assocham). "When the whole world was reeling under global slowdown, the domestic healthcare sector registered healthy growth during the first quarter of the current fiscal," the chamber said in a study "Financial Health of the Indian Healthcare Industry". http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare-/-Biotech/Healthcare-industry-grew-42-percent-in-first-quarter/articleshow/4950726.cms

Biocon sees India biz growth, boost from Mylan pact

BANGALORE: Biocon Ltd, India's top listed biotechnology firm, expects its branded formulations business in India to double this fiscal year as it
launches new products, its chairman said.

Biocon, which makes insulin, cholesterol-lowering statins and other branded drugs, is also talking to companies to license out its oral insulin, the clinical trials of which are expected to end in March next year, Kiran Mazumdar-Shaw told Reuters in an interview on Tuesday.


http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare-/-Biotech/Biocon-sees-India-biz-growth-boost-from-Mylan-pact/articleshow/4935449.cms

More than 400 reports of suspected adverse reactions to oseltamivir (Tamiflu)

Over 400 reports of suspected adverse reactions to Tamiflu have been recorded since April this year, figures from the drug safety monitoring body show. Figures due to be published by the Medicines and Healthcare products Regulatory Agency (MHRA) later this week will show that there have been 125 events reported in the past week alone. Between 1 April and 6 August there have been a total of 418 reports of 686 suspected adverse reactions to Tamiflu.
http://www.drugscontrol.org/news.asp?id=4353&hl=More%20than%20400%20reports%20of%20suspected%20adverse%20reactions%20to%20oseltamivir%20(Tamiflu)

New AIDS vaccine ready for Human Trials

The Canadian University of Western Ontario has developed a new HIV/Aids vaccine that is ready for human trials.The vaccine called SAV001H has been developed by the university at London, about 160 km from Toronto, in collaboration with Sumagen Canada, a subsidiary of the Korean pharmaceutical company.In a statement Tuesday, Sumagen Canada said it has submitted an application to the US Food and Drug Administration (FDA) to begin the first phase of trials of the vaccine on human beings.Chil-Yong Kang, a professor at the university, said they have completed safety and immunogenicity studies of the vaccine on animals. Immunogenicity measures the ability of a drug or vaccine to provoke an immune response in the body. Trials of the new vaccine on animals have reportedly resulted in good anti-body reactions with no adverse effects.

Numerous trials have been carried out by pharmaceutical companies to develop vaccines , but no commercialised vaccine has been developed so far. Sumagen Canada has secured patents for the vaccine in over 70 countries, including the US, the European Union and Korea.It said the phase one clinical trials of the vaccine will double check its safety on HIV positive volunteers. The phase two trials would assess the immunogenicity of the vaccine. Sumagen Canada said it is ready for clinical trials in the US as soon the FDA approval is granted.The University of Western Ontario and the city of London have been short-listed by the Canadian government to set up an $88 million HIV vaccine manufacturing facility, which will be partly funded by the Bill and Melinda Gates Foundation.Last week Canadian scientists had announced a major breakthrough in Aids treatment by saying that they have found where the HIV virus hides in the human body.Currently, Aids patients have to take a cocktail of six drugs to prolong their life up to 13 years. There are over 33 mn HIV patients worldwide, with 2.7 million more getting infected each year.

Source: Clinical Research Forum

Swiss CRO moves into Indian clinical trials market

Switzerland-based contract research organisation PFC Pharma Focus has set up an Indian subsidiary with the help of Excel Life Sciences, a US firm that specialises in running trials in India.PFC India will be based in New Delhi and offer clinical trial support services such as study planning, monitoring, audit and data management services to biopharmaceutical companies and other CROs.India is fast becoming a global hub for clinical research, with the number of trials carried out each year growing by 50% a year, according to PFC. That view ties in with a report published by RNCOS earlier this year, which found that at present around 2% of all clinical trials in the world are carried out in India. That proportion is expected to more than double to 5% by 2012.The rapid growth is expected occur on the back of India's huge pool of potential trial participants, ease of recruitment and cost savings that could slash the cost of trials by 50-75% compared to the US or Europe.The new PFC India venture "combines the strengths of a long standing and successful European CRO" with ELS' "local expertise," PFC and ELS said in a joint statement.Their New Delhi unit will allow them to "offer our clients access to a large diverse patient population as well as to a significant number of patients suffering from rare diseases", said PFC's chief executive and co-founder Dr Kurt Pfister.Despite India's potential, there have been some brakes on growth, including some scandals relating to unethical trials, delays in approvals, inadequate protection of clinical data and a lack of Good Clinical Practice-compliant sites and investigators. Last year, for example, the industry suffered a knock to its reputation after an investigation was launched into 49 infant deaths seen during trials carried out by the All India Institute of Medical Sciences (AIIMS) in New Delhi. The Indian government recognises that clinical research could be a major growth industry in the country, and has been taking steps to improve oversight of the sector. Last week it implemented a scheme whereby all companies conducting clinical trials in the country are required to list studies in a registry operated by the Indian Council of Medical Research (ICMR).The register has run for a couple of years on a voluntary basis, but is now a legal requirement. It is freely accessible to the public. "The Drugs Controller General's office of India is stepping up its compliance standards," commented Dr Vijai Kumar, president and chief medical officer at ELS.At the same time, "pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand," he added.

Source: www.pharmafocus.com

SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application

SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application Suite Offers fully automated capabilities in management of clinical trial process, clinical trial data and global adverse event reporting MUMBAI, India, Aug. 5 /PRNewswire/ -- SIRO Clinpharm, a global, full service Contract Research Organization (CRO) founded in India, today announced the successful completion of the implementation phase of the Oracle Life Science Application Suite (OLSAS) by going live with Oracle Siebel Clinical Trial Management System and Oracle Adverse Events Reporting System. "We are excited to have the rollout of the entire OLSAS as per our plan for the India operations," said Dr. Ajit Nair, President, India Operations, SIRO Clinpharm. "This will help us manage critical tasks in clinical operations and drug safety in an efficient and globally compliant manner, thus providing our clients the best of technology support to run trials more efficiently." After this implementation, SIRO gains complete operational functionality of the Oracle suite. SIRO, in April, had gone live with the industry standard Oracle Clinical and Oracle RDC, integrated with TMS for its Clinical Data Management Services. The OLSAS product portfolio for SIRO is comprised of Siebel Clinical Trial Management System 8.0 (CTMS), Adverse Events Reporting System 4.6 (AERS), Oracle Clinical 4.5.3 (OC), Remote Data Capture 4.5.3 (RDC) and Thesaurus Management System 4.6 (TMS). SIRO plans to roll out the OLSAS to its European operations soon to have the system working in all geographies in which the company has operations.

About SIRO
SIRO Clinpharm Private Limited (SIRO) is among one of the leading global Clinical Research Organizations (CROs), offering full scope services, conducting clinical trials in the pharmaceutical, biotechnology and medical devices sectors in compliance with international standards. SIRO is one of the first CROs founded in India, which caters to the needs of pharmaceutical companies across the world. The company has offices in India, USA, Israel and in Germany, Romania, Estonia and Greece. SIRO has recently opened offices in Czech Republic & Spain.

SOURCE SIRO Clinpharm

Human clinical trials for stem-cell research on cards

In what is seen as a boost to the stem cell research in the country, India would soon get to host human clinical trials for therapies using umbilical blood cord (UBC) stem cell. Chennai-based Apollo Hospital, America’s largest stem cell company StemCyte and Dr Wise Young, a leading expert on spinal cord injury, are in talks for conducting clinical trials in India using stem cell derived from UBC.
view full info at http://economictimes.indiatimes.com/News/News-By-Industry/Healthcare-Biotech/Human-clinical-trials-for-stem-cell-research-on-cards/articleshow/4875516.cms

Clinical Data Manager

Here's one more article on job prospects of CDM.

The workplace changes as the world changes as well. Before there were only a few jobs people can choose from – that of a teacher, farmer, doctor, nurse, lawyer, policeman, soldier, firemen, and other plain old jobs. But now, different trades and processions are emerging each year, making the employment scene quite rich and thriving. Apart from being interesting a lot of these jobs are lucrative as well. One great example of such new interesting and profitable positions is that of the clinical data manager. Looking at its responsibilities it seems to be rather a mentally stimulating job, and the buzz is that the salary range is attractive as well. An attractive salary is not only what lures people into applying for the clinical data manager position, the challenge of the job seems to be quite as fulfilling. The job entails a mixture of the medical field and information technology The manager is responsible for tracking and consigning the database system of a medical or clinical institution. The job may be within a health care system or a research facility. The clinical data manager supervises the work of data clinical data entry associates to ensure the accuracy and consistency of the data after it has been entered in to the system. This is important to meet the quality standards needed to report to medical regulatory bodies. The job of the clinical data manager is an essential part of the whole clinical setup as it deals with management of the information that would help the better understanding of patients or the clearer analysis of clinical studies. An efficient data base of the clinical data is necessary not only to keep records in the hospital or research facility, it also plays an important role in the proper administration of health care to patients. Many hospitals and research facilities consider their clinical database to be among their most important assets that really have to be kept in proper order. And it is the responsibility of the clinical data manager to maintain such. The clinical data manager positions requires the combination of knowledge and skill in both the medical and technological fields. The manager should have great facility in working with computer systems since he will be handling a wide scope of computer applications used for the collection, management, and retrieval of data. In conjunction with this, the clinical data manager should be also adept with medical knowledge, familiar with pharmacology, well versed in clinical procedures, and comfortable in medical jargon. The job basically entails merging the medical and the technological and so it is expected that the manager be good in both fields. With such an important responsibility and a matching salary to boot, it is just expected that the clinical data manager position would require a considerable set of qualifications. Usually, a minimum of a bachelor’s degree is required with a concentration on a scientific or related field. An extensive experience in clinical data entry is needed of usually around five years in a medical or research institution. Certification in medical database systems is very much an asset for applicants together with a working knowledge in medical terms, codes, conditions, and drugs. Since it is basically a managerial job, work independence and leadership skills are expected together with good communication skills. Now perhaps the most exciting part of this job, the salary. The clinical data manager may indeed be a financially substantial position. Entry-level managers may earn as much as $80,000 to $100,000 a year. Those in higher positions may get as much as $250,000. With such an exciting job with a substantial salary, the position of the clinical data manager may indeed be attractive. So for those who have the skill and the drive for this occupation, trying out for the stint may be well worth it.

More about Clinical Data Management

One can readily have no problem in accepting the fact that understanding the value of information in the day-to-day operations of a firm is a fundamental criterion in the formation of an effective data processing and management strategy.
Clinical data management is just another branch of the overall tree of data management. There are a number of clinical data management service providers who offer their client’s companies a comprehensive portfolio of clinical research based on the data that has been processed. These services include project management, clinical monitoring, medical monitoring, and the attainment and management of data.
Clinical data management is gaining an important place in the field of data processing and management services. As time is rolling by, more and more health and medical companies feel the urge to switch to clinical data management for various electronic drug development solutions. These kinds of drug development solutions enhance the effectiveness of pharmaceutical companies by merging the day-by-day planning and implementation of clinical trials with powerful data-integration and analysis.
Clinical data management, being the method and structure in place for monitoring data, is an excellent way to keep all financial and health information in order in a clinical situation. You can link and cross-reference bits of data for the purpose of creating knowledge, rather than just raw information. A clinical data management program or company will save you time and money in the long run, allowing you to focus on the actual workings of yout clinic, rather than the specific details of quantity and so on.
Data Management provides detailed information on Data Management, Data Processing And Management Services, Data Management Software, Clinical Data Management and more. Data Management is affiliated with Data Recovery Services.

Free CAPA training with certification

Hi there
Here's a link for newbies in clinical research so that they can understand the CAPA concept. Very nice module..

http://nortoninstitute.coursehost.com/engine/Academic/Tools/CoursePublicize.asp?pk=27182&LID=1&ky=d_BPDiQVRgHzDiPRUmf_DgHzJ47OL3vz

Why CDM

As subjects get bifurcated, job profiles are getting diversified. Back in the days there were pure science subjects such as physics, chemistry and biology. Physics later gave way to branches such as radio- physics; chemistry got diversified with cheminformatics and biology as bioinformatics.

With a growing range of subjects, job requirements have undergone massive changes. Today one such preferred industry is Clinical Research Industry. During the last three years this industry has achieved growth from Rs. 20 crores to Rs. 100 crores. Clinical research, Clinical trial, Clinical data, clinical content management are all inter-related field and fall under the scope of biotechnology, microbiology, biochemistry and genetics.

Mother subjects like biotechnology, microbiology biotechnology is no more restricted to petriplates, pipettes, conical flask and chemicals-which is know as ‘wet lab systems’. It has expanded its wings to ‘dry labs system’. The dry labs basically emphasizes on -Sequence analysis, drug toxicity, pharmacokinetics studies, market analysis, biometrics (statistical analysis), regulatory affairs of new drugs, which in turn makes up the clinical data management studies. Dry Labs use software and other programming languages to accomplish data management work. Now researchers are combining proteomics, genomics with modern technologies, in order to make biological data systematically organized into databases and easily accessible to common people.

Basically any data related to clinical, health care, or medical studies is known as clinical data and managing these data in order to reduce the possibility of errors due to human entry is known as “clinical data management systems.”

Getting into the details of this field, it basically deals with new drug discoveries, its efficacy and efficiency to serve the human race. The process is something of this kind:
A drug is developed
Drug’s efficacy and toxicity level tested on animals (preclinical studies)
Drug’s efficacy, efficiency and toxicity needs to be tested on humans (clinical studies)
This whole study process is taken care by the CRO'S - contract research organizations.

While the data gathered during the above mentioned process needs to be
Collected
Validated
Data entry has to be made
Analysis (statistical analysis)
Maintained in database.
These tasks are performed by SMO's - site management organization.
The SMO'S and the CRO'S together form what is known as RMO- RESEARCH MANAGEMENT ORGANIZATIONS. Hence CRO’s and SMO’s deals with clinical data management projects.


New drug discovered
(Clinical trials)
CRO
(Trial performance)
RMO
(CRO+SMO)
SMO
(Maintaining data of trial)
­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Accordingly job profile changes with the kind of institute you are linked up with. CRO concentrates more on fieldwork like-
Visiting the investigation sites,
Monitoring the trials,
Monitoring the patients data-CRF forms,
Checking the ethical issues of the trial
Informed consent of the patients etc.

Whereas SMO becomes an office oriented work, where each data needs to be closely scrutinized, validated, analyzed, planning of budget development of the trial, business development, medical coding etc. Most IT or software companies involved in clinical trial management projects can be called SMO, as it requires least field work of monitoring trials and visiting the trial locations or the investigating sites. Setting up an SMO needs less investment and minimal infrastructure set up. Few such software firms outsourcing clinical research projects are:
Accenture.
Infosys
IBM
TCS
Cognizant Technologies
ICTEAS

CRO'S employs professionals such as- CRC (Clinical research co-coordinator), CRA (clinical research associate), senior clinical research associate, project managers, Investigators etc. SMO's employs-CDC (clinical data co-coordinator), clinical data analyst, clinical project managers, biostatistician, medical writers. Now life science candidates have more choice in their field. It is not only restricted to wet labs but also dry labs with bioinformatics, clinical research, and clinical data management gaining more popularity. It mainly deals with knowledge outsourcing and it’s quite a lucrative field for both the employer and employee.

These organizations ensure smooth, accurate progress of clinical studies from product development, planning and approval stages through study completion and post-study closure. It is essential to prepare documents for submission for review by the Institutional Review Board (IRB), next recruiting and screening study participants, coordinate their clinical treatment and follow-up their treatment as it proceeds further, and counsel them as and when required to enable their continued participation in the trial;
Similarly data collection from medical records, journals, abstract curation, submitting data and maintaining study data and regulatory documents; developing and ensuring compliance with study protocols; and participating in the method development, and budgeting for clinical studies or clinical trials all forms a part of clinical trial data management.

India is global hub of outsourcing for clinical trials, since it has got high population of cancer patients, wide spectrum of diseases such as cancer, diabetes and other maladies. Pharma companies, the major players in the world are attracted towards India as one of the clinical research destination since it has got huge patient population, multi specialty hospital beds, medical colleges with efficient investigators and trial personnel and skilled English speaking professionals.

Another major aspect is the cost factor; the cost of drug trial gets drastically reduced when a particular trial is being conducted in the Indian sub-continent. Today big pharma giants like Glaxo, Aventis, Abott pharmaceutics, Bristoll –Myers Squibb, Covance, Novozyme, Eli Lilly, Pfizer, Novo Nordisk is showing their interest in showcasing their drugs by conducting trials at various Indian cities.

In order to make this clinical research more popular and accessible to common people- ‘online clinical trial registry’ is being set up. This trial registry gives information of the various ongoing open trials. Indirectly it is popularizing the whole concept of drug discovery, efficacy, and attracting more trial participants or volunteers. These registries are improving the transparencies of trials by disclosing the patient accrual, dose administered, drug combinations, side effects related, patent status of the drug, investigators details (attached to a particular trial). As a result a clear picture is put up before patients or participants that might lead to enhancement of public tolerance and confidence towards Clinical Trials in India.
The major aspects which is taken into count while conducting Trials in India are:
High population rate
Specialty Hospitals
Availability of talented doctors
Skilled professional
Sufficient sales potential (marketing of drugs)
Patent protection act
Cost effective.
Among all the cities Hyderabad runs the highest number of CRO’s, next in line are Bangalore, Mumbai and Delhi. Quintiles, Dr. Reddy’s Lab, Reliance life sciences of Bangalore, Hyderabad, and Mumbai respectively are expanding their data management team. Need for clinical trial professional, biostatistician are ever increasing. Pharma giants have joined hands with pharmaceuticals and biotech industry such as TCS has joined hands with Eli Lilly and Novo Nordisk, Accenture with Wyeth group.

To make the identity of clinical data manager professional prominent various clinical data management society is being formed for example:
Association of clinical data managers (ACDM).
Society for clinical trials
The American statistical association
The Regulatory affairs professional society.
This field can offer its professionals with good career progression, increase in income, exposure to cutting edge technology, and immense chances of overseas travel. It can provide opportunities to best minds in the industry. Starting from entry-level jobs as clinical research associate and coordinators to Clinical Project managers and business development managers it is a promising path of success. Thus the main aim lies in developing protocols and maintaining medical data, medical codes in compliance with GCP (Good clinical practice). Good Clinical Practice guidelines provide ethical and scientific standards for designing, conducting, recording, reporting, monitoring, auditing, analyzing and reporting clinical trials. Hence it is a kind of extracting high quality data by proper validation and statistical analysis and forecasting future results with greater predictability.

Source : Biospectrum

Welcome To CDMPortal

Welcome to the CDMportal. This Blog is created so that one understands what is Clinical Data Management, its scope as a career and anything and everything about CDM.