Dr Sanjeev K Chaudhry, CEO, Super Religare
Laboratories, New Delhi
Dr Sanjeev K
Chaudhry is presently the chief executive officer of Super Religare
Laboratories; director of Religare Wellness; and chairman of CSC
Nutrigenomics, Singapore. He was the South Asia Head of Solae, a joint
venture of DuPont and Bunge, for 11 years, until June 2006. In 1989, Dr
Chaudhry, at 30 years of age, became the youngest CEO of a public
service company (PSC) in India. He earned accolades for turning around
the ailing state-owned Modern Food Industries. He presented the
privatization plan of India’s first state-owned enterprise to the
Planning Commission.
With increasing emphasis on treatments that can improve and prolong
human life, pharmaceutical companies are under continued pressure to
provide enhanced and newer therapies. This has led to an explosive
growth in new drug research. The areas that have seen the largest
growth include emerging markets such as India, Asia Pacific, parts of
Eastern Europe, Africa and Latin America.
The increased number of clinical trials in trial-näive countries
is posing significant challenges to regulators all over the world. To
overcome these challenges, regulators in the US (US FDA), European
Union and Japan are putting considerable emphasis on:
- Validation of scientific methodologies to verify if the study
will yield reliable and interpretative results
- Selection of patients through a robust informed consent process
- Strict adherence to inclusion and exclusion criteria as defined
in the trial protocol
- Continuous monitoring of safety data
- Analysis of any adverse events and/or serious adverse events to
balance risks and benefits of the trial
- Adherence to International Conference on Harmonization-Good
Clinical Practice (ICH-GCP) guidelines
The central laboratory services provide the crucial infrastructure and
support to the pharmaceutical industry to address these critical
issues. Selecting a reliable central laboratory provides consistent
quality, complete, secure, timely and retrievable data and accurate
reporting.
A central testing laboratory provides support functions like data
management, information technology, project management, operations,
logistics, kit assembling, quality assurance, accessioning and
materials.
Accreditations such as college of american pathologists (CAP) and
national accreditation board for testing and calibration laboratories
(NABL) ensure technical competence of the staff, instrumentation,
methodologies, documentation, and also endorse quality framework and
its management systems that need to be followed to perform and report
reliable and clean results.
It is absolutely critical to have a reliable central laboratory, as
this will set the trend for inclusion/exclusion criteria, unbiased and
blinded reporting, customized database, confidentiality of data,
subject protection and finally, the future of the drug under
evaluation.
Key
differentiators that a central laboratory brings on table
- Reliable testing and calibration services
- Reliable delivery of accurate and timely data
- Test design and statistical validity
- Primary instruments as well as the backup
instruments/methodologies in place, that ensure business continuity and
reliability
- Setting up and validation of protocol-specific laboratory
assessments, or conduct method transfer and validations
- Flexible reporting options in terms of conventional and SI units,
flagging of critical alerts, deltas, trend analysis
- Support to extensive menu of safety and specialized clinical
testing
- Seasoned and GCP-trained operations staff, ensure business
continuity and safety compliance
- Support to a wide range of therapeutic areas