Indian Society for Clinical Research (ISCR) has formed the Southern Chapter with 50 members. The key objective of the formation of the Chapter is to represent the southern region primarily to address issues relating to regulatory framework and site management.
The first meeting which took off in Bangalore at the office of Icon Clinical Research was primarily to announce the office bearers and take the activities forward, stated Dr Krathish Bopanna, senior vice president, Manipal AcuNova and Convener, Indian Society for Clinical Research (ISCR), Southern Chapter.
The Southern chapter of ISCR represents the states of Karnataka, Tamil Nadu, Kerala and Karnataka. There is considerable clinical research activity going on in these states which is attributed to the presence of leading hospitals supported by medical professionals. Therefore a need for a dedicated Southern Chapter was inevitable, stated Bopanna.
The formal overview of ISCR objectives and mission along with a discussion and interaction with members on how to take ISCR regional chapter forward, build capacity at sites, resources and co-operation amongst members, were the key highlights of the inaugural meeting in Bangalore.
The Indian Society for Clinical Research was launched in August 2005. The formation of the Society provided a platform to the clinical research organizations.
It currently operates through six functional councils: training council, regulatory council, media/events council, ethics council, CDM & bio statistics council and investigator council.
The society is expected to influence the future of clinical research in India by intensifying efforts to encourage high standards of science and ethics, shape regulations & policy through a process of constructive dialogue and create a network for training & information exchange.
The first Annual Conference of the Society in January 2008, has helped ISCR to be recognized not only among its members but also government departments with whom it actively collaborates to discuss and iron out issues related to clinical research in India.
There are two types of membership: AMO (corporate) and Individual. The ISCR national has around 300 individual members and 17 AMOs as members. The AMOs are: AstraZeneca, BMS, ClinInvent, Clinsys India, Crema, Eli Lilly, i3 Research, J&J, Manipal Acunova, MSD, Neeman Medical, Novartis, Pharmanet, Pfizer, Quintiles, Reliance & Siroclinpharm.
Events conducted during last one year by ISCR included Training Council's 3-day workshop on "A to Z of Clinical Trial Process" at Mumbai & Bangalore in June and October 2007. "Effective Clinical Trial Project Management" in April & May 2008.Ethics Council initiated "Draft Guidelines for Compensation to Participants for Research related Injury" being discussed and formulated with help of various stakeholders. Finalized document is to be jointly issued by ICMR, FERCI & ISCR. Regulatory council meetings with DCGI & DGFT for streamlining procedures and uploading "Guidance Documents for Regulatory Submissions" on the ISCR website.
Some of the forthcoming Activities will be three workshops on "Advanced Monitoring", Pharmacovigilance", and "The ABC of Drug Development," in the second half of 2008, Joint initiative by ISCR at Nair Hospital - BMJ for a 2-day workshop on "Medical Writing." in September 2008. "ISCR Awards 2008" on October 16, 2008 at Mumbai CDM & BS Council's "Awareness Survey and Training" programmes, launch of ISCR Journal at the second annual conference in January 2009 besides Training courses under the joint ISCR-ICR Tie-up to be held at Delhi, Bangalore and Mumbai.