In today’s ever-changing and dynamic life sciences industry, even the word “consulting” can seem overused and if not, then it is at the very least, vague. Typically, consulting is offered by a Clinical Research Organization (CRO) to support biotech and pharma clients in developing study designs. Why consulting is important, how it benefits the clinical trial process and its industry-wide reputation are all widely debated topics that could use some clarification.
First, the need for consulting operations often comes out of the growing recognition of a knowledge gap in the industry and the strong momentum of ongoing internal consulting opportunities. Consulting can be sought at any phase of development, but even as early as the preclinical stage of R&D when the strategy for the program is being developed.
The strength of consulting very much depends on the consultant team – their diversity of expertise, experience, and tech-savviness. A versatile team is always best; especially when they are deeply rooted in clinical research with expertise shaped in various stages of R&D programs (this can range from agency experts and clinical managers to specialists from the health technology assessment area). At KCR, our consulting expertise is additionally reinforced by our expert medical team of physicians and clinicians, making the service fully comprehensive.
In parallel to consulting services, standard trial execution services can be dispensed simultaneously, which can help secure the smooth transfer of the knowledge gathered in the pre-trial consulting venture. Furthermore, consulting support does not have to stop as the project transfers to initiation. When needs arise, consultants can be brought in to offer subject matter content, innovative solutions and expert-based oversight.
Consulting as a service is mistakenly assumed to come with very high levels of investment. However, in reality, the average consulting project constitutes <1% of total costs related to single clinical trial, while the knowledge and feedback obtained in the process is immensely influential, often critical, for project commencement and proceedings.
Another misconception is the idea that the client gives away control in clinical proceedings because valuable information is being held in the CRO’s hands. In truth, the sponsor both owns all information and insights and gains the power to make big decisions in an informed manner. Therefore, consulting gives clients greater control, because it equips them with high-level information to ensure informed decision making for program strategy and optimization.
Consulting empowers clients with precise strategic and operational information to ensure they can make informed decisions on their clinical program’s shape, continuation and commencement.
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About The Author
Dr. Anna Baran
Chief Medical Officer and Head of Trial Execution Consulting, KCR
Dr. Anna Baran is Chief Medical Officer and Head of Trial Execution Consulting at KCR, clinical development solutions provider for the biotechnology, pharmaceutical and medical industries, operating internationally. Dr. Baran has extensive clinical and medical experience having conducted research for pre-clinical and clinical projects over the years and providing drug development consultancy for R&D projects across different countries.