Page 175 - CW E-Magazine (24-9-2024)

Special Report

End user trends in CRO industry areas, such as oncology, rare diseases, Pharmaceutical companies prefer to
Pharmaceutical and biotechnology immunology, or personalized medi- work with CROs that have experienced
companies continue to be the primary cine. Pharmaceutical and biotechno- Project Management team, which can
end users of contract research services. logy companies seek CROs with deep communicate effectively and provide a
There has been emergence of some other knowledge and experience in specific consultative, value-added, and transfor-
sectors like the academic research insti- areas to support their R&D efforts. mational approach towards the clinical
tutions, medical device companies and Pharmaceutical and biopharmaceutical trials.
nutraceutical companies, which have companies have started opting for small
started outsourcing contract research to to medium size CROs for their clinical The BA/BE CROs with strong regu-
specialized CRO service providers. development requirements. They are latory experience with the clinical trial
beginning to adopt a nimbler business audits and inspections from interna-
There has been an increasing focus model of innovations. One of the charac- tional regulatory bodies like USFDA,
on strategic partnerships with CROs teristics of this more agile model is a EMEA, TGA, ANVISA are preferred
to foster long-term collaborations and shift in emphasis toward mining many as compared to the CROs with only
drive innovation. This involves pre- early innovations externally (instead of national regulators.
ferred provider agreements, risk-sha- prioritizing several high-cost programs) –
ring models, and joint development of via open science, venture funds, Compliance to ICH-GCP, HIPAA,
drugs or therapies. Recent research from industry-academia partnerships, acce- HITECH, the Privacy Rule, GDPR, and
the University of Cambridge suggests lerator programs, etc. to come up with any other applicable law and regulation
there has been a significant change in the potential pipelines of products and of the country concerning data privacy
how pharmaceutical firms interact with ‘killing’ projects early so as to choose and patient confidentiality is one of the
CROs, with a clear shift towards strate- only the most promising and validated most important factors for the sponsors
gic alliances over one-time transactions. programs for development. while selecting the CROs for clinical
The data shows that while a quarter of studies.
outsourced projects still use a transac- From the pharmaceutical company’s
tional approach, the remaining 75% are perspective, the potential partner Clini- [Executive summary of study con-
split between preferred providers and cal Trial CROs or Bioequivalence CRO ducted by the Department of Pharmaceu-
strategic partnerships, highlighting a should be affordable, financially stable, ticals, Ministry of Chemicals & Fertili-
preference for long-term collaborations. have a brand image, strong Quality zers, Government of India, August 2023.
Management System (QMS) and expe- The full report can be found at: https://
There is a growing demand for spe- rienced teams with the subject disease www.pharmaceuticals.gov.in/study-
cialized expertise in niche therapeutic and/or indication and study phase. report]

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Chemical Weekly September 24, 2024 175

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