Establishing pharmacovigilance programme

1. Contract research
organization
Miss. Gayatri K. Bahatkar
Assistant Professor
P. R. Patil Institute of Pharmacy, Talegaon sp

2. Definition
• A person / organization contracted by sponsor to perform one or more
of sponsors trial related duties and functions.
• CRO- are service organization that provide services to wide variety of
business like pharmaceutical industries, biotechnology industry ,
medical devices industry, govt institution , foundation , university.
• A Contract Research Organization (CRO) is a service organization
which provides support to the pharmaceutical industry.
• It offers various pharmaceutical research that is essential for
conducting clinical trials in the present boom, when various
complications are involved in the drug discovery process.

3. • Various companies are involved in his type of development many
examples are the like Lupin , Quintil, Cipla, Zydus, Cadeila.
• They are also conduct these type of trails with the collaboration of
many multinational companies and these Indian companies are making
space in foreign.
Need
• To save funds
• To save time
• Specialized services by specialized professionals

4. History
• Oldest CRO- food and drug research laboratories (1980) new jerrcy-
closed in 1980
• 1975 and onward- there are many CRO generated and some are
bioassay system, tegaris ,bushy run, HTI and Charles river laboratories
that further slowly so many CRO emerged and due to economic
pressure they are some kind of activity those activity known as merger
as well as closer.

5. Services provided
• Biology- in vitro , in vivo, toxicology, lead identification, lead
optimization, efficacy modeling, PK and PD.
• Chemistry – scale up synthesis ,API manufacturing, radio synthesis,
analytical, bioanalytical method development , validation .
• Clinical services- phase 0, phase 1 to 3, site management, biostatics,
report writing, PV.
• Pharmaceutics- formulation development, drug product manufacturing
• Drug regulatory- IND filing, NDA filing, Pre market approval CTD,
Drug master file, Annual update .

6. How to select CRO for out sourcing
• Dependability
• Prior experience with activity / specific study
• Training of person
• Status/ type of equipment required to perform study
• Cost of the project
• State of facility
• Regulatory history of the organization
• State of IT system
• Financial soundness

7. • Physical location and accessibility
• References and reputation
• Procedure in place to protect client confidentially
• Acceptability of study scheduling
• Format and details of study protocol
• Company position authorship
• The on time report delivery
• Openness to inspection by the spencer's
• Term of masters services agreement
.

8. Role of contract research organization
• It provide support to the pharmaceutical biotechnology and medical
device industries in the form of research services out sourced by
contract basis.
• It is increases interdisciplinary collaboration and enhanced uses of
advanced technology
• CRO is responsible for planning set up and day to day execution and
management of its contracted clinical trial
• Handling and supervising the technical side

9. Main responsibilities that are completed by a CRO.
• 1. Implementation of systems and procedures for the conduct of clinical
trials and assessment of the safety in carrying out those trials.
• 2. Taking complete responsibility to ensure that the CTS are conducted in
accordance with the guidelines and regulations, whether they are specified
by the pharmaceutical industry or by the companies they are carrying out
the research for.
• 3. Following the terms of the research contract it has signed with the
sponsor.
• 4. Communicating concerns associated with the trials to the sponsors on a
regular and timely basis. These concems include the progress in the trial,
complications, risks and more
• 5. Assuring to maintain quality and metrics throughout the procedure in
order to get the accurate and unbiased results.
• 6. Last but not least responsibility of a CRO is to record the trial results and
maintain accuracy in all those records.

11. Establishing national PV programmed
• In India ADR monitoring system started in 1986 with 12 regional
center.
• 1997 India become member of WHO programmed for IDM managed
bye UMC.
• Initially we have 6 regional center- new Delhi, Mumbai, Kolkata,
Lucknow , Chandigarh, Pondicherry.
• 2004- india launched NPVPI -0.1 million world bank gant- ended
in2005
• 2010- health ministry launched – PvPI –AIIMS (NCC)- IPC (NCC) (Dr,
G.N.Sing)

12. • Under PvPI – ADR monitoring started @ AMC- across medical college
(MCI approved)
• AMC become responsible – collect ADR as per SOP and talking follow
up – upload to vigiflow
• Individual case safety report ( ICSRs) are collected in predesigned ADR
report form – 4 section
1. Patient info
2. Suspected adverse drug reaction
3. Suspected medicine
4. Reporter information

13. • This ICSR reports to the NCC for quality and signal review – WHO
UMC causality assessment system.
• 2006-2008- ICSRs 11633 ICSR reported :2009-2014- 78672 ICSR
reported- so reporting increases
• Besides ADR reporting, PvPI develop medicine side effect reporting
form in regional language of India
• However the present database of ADR on PvPI is not sufficient to
represent the population which consume drugs
• Encouragement requires- physician , pharmacist nursing and
paramedical staff, patient, pharmaceutical Company.
• Communication must needed- P-P-P-P
• Financial incentive for medical and non medical staff

14. • Lack of time and overload
• Ignorance’s
• Required training programme , advertising
• Reporting of serious ADR
• Appointment of PV officer at every govt and private hospitals
• India contribution in Vigibase database was 2% till 2013

15. CDSCO Stakeholders
UMC Sweden
National health
program
Pharmaceutical
company
Professional bodies
And forwarded to
NCC – IPC Gaziabad
• Signal review panel
• Core training panel
• Quality review
panel
As well as the
Strategic advisory
committee
Steering
committee take a
decision
CDSCO zonal and subzonal office
North, south, east, west zones
AMC
Report
informed