25 July 2018

#KCR_Trends: The value of experience: Consulting in Trial Execution

In previous posts, we have discussed how CROs are differentiating their product offering to adapt to different clients’ needs and how they are resorting to innovative models to acquire skills and know-how.

In that sense, CROs are not simply adapting their clinical trial service offering to match the specific needs of sponsors. An equally profound change has quietly been taking place in the industry over the years; the growth of medical scientific consulting as a specific segment of the industry.

As Anna Baran, KCR’s Chief Medical Officer, says, “The clinical research industry has become very complex nowadays, with great time and cost pressure”, e and evidence of this complexity is clear. In recent years, the industry has moved at an astonishing pace: science and technology have advanced so dramatically that new frontiers for therapies are appearing (two clear examples are CAR-T therapies and CRISPR/CAS9 gene editing technique), regulations have changed swiftly and the public is more conscious and aware of health issues. This, in turn, has resulted in companies often being unable to deal with the current landscape, due either to a slow pace of change internally or an absence of internal capabilities, with the former usually associated with middle and large-sized pharma companies, and the latter usually with small pharma and biotech.

The areas in which pharma requires consulting will certainly continue to grow as the industry evolves in the coming years.

In such a context, pharma companies often find themselves in need of highly specialized scientific advice to assess and further their assets; may it be protocol writing or development, medical monitoring, pharmacovigilance services, assistance with regulatory affairs (from the clinical trial to the market access perspectives) or many other areas such as pricing and reimbursement, marketing and manufacturing. The areas in which pharma requires consulting will certainly continue to grow as the industry evolves in the coming years.

Pharma consulting as a segment is so broad that it is difficult to make sweeping generalizations about it, but the value proposition of consulting companies can be summarized in 2 options: the vertical integration alternative, in which companies offer a “one-stop shop” to provide all services under a single roof, or a niche model in which companies offer highly specific services in a “boutique” setting. In any case, the value for clients lies in the wealth of expertise and knowledge gathered through the execution of trials over the years.

KCR has recently expanded its service, offering Trial Execution Consulting to our clients across our 4 hubs: Boston, Berlin, Warsaw and Kiev. Our new service is bolstered by more than 20 years of experience in the clinical trial market and our goal is to support our clients in translating scientific objectives into operational activity and success. As Mike Jagielski, president and chief executive officer of KCR said, “The new service is a great opportunity to assist our biotech and pharma clients in being successful with their studies on an international level. By adding Trial Execution Consulting to our services portfolio, we can continue to offer boutique, customized and fully responsive solutions to meet our clients’ specific requests.”


Sources: A Medium Corporation

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