Peri-Approval studies begin at regulatory filing or when pivotal trials
are nearing completion and extend through approval, the launch period
and the remaining development life cycle of a drug. The Chiltern
Peri-Approval services will cover Phase IIIb studies as well as Phase IV
type studies, including Post Authorisation Safety Studies (PASS),
Randomised Controlled Trials (RCTs), Outcomes and Registry studies.
"Previously, little attention was paid to Peri-Approval in Europe, although the concept has proved more popular in the US pharmaceutical market," commented Jess Sohal, who is in charge for heading up the new service. "We intend to meet the US demand for Peri-Approval services, as well as focusing on the growing need in Europe and elsewhere.
"Over the past few years, there has been a change in behaviour amongst
many of the pharma companies. With the regulators focussing more and
more on safety, and with less than planned new product launches
Peri-Approval strategies have become more and more important. They now
make up a significant part of development and augment new product
launches, the earlier loss of product exclusivity and the rapid generic
erosion of sales following the expiry of patents.
"Pharma companies are re-allocating their development budgets to include
Peri-Approval studies to maximize their 'product assets' whilst their
products are still covered by patents," she went on to explain. "Led by
big pharma, the industry has adopted 'full product life cycle
management' philosophies, with attached budgets to better plan their
"The EU experienced its biggest phase of enlargement in 2004 and the
pharmaceutical market is still undergoing changes as a result. In the
medium to long-term we envisage a particular regional increase in demand
for post-marketing services. At present, the newer EU entrants are
experiencing massive trans-national flows of investment from the more
established European industry players. This will serve to increase the
EU pharmaceutical market and create incentives for pharma to invest more
in Peri-Approval activities in the accession countries."