Outsourcing in the Pharmaceutical Industry – How to Engage, Manage and Monitor CRO Activities

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Dan Levy, Guest Blogger 

https://hamptonexecutivesearch.com

Who is your CRO?

DEL BioPharma Consulting Services for Drug Discovery Programs

Dan’s blog

In today’s industrial climate, use of contract research laboratories is no longer the exception.  These days, such groups not only augment established in-house resources, they also frequently serve as the sole source of chemistry activities for many organizations.  As this trend continues, those new to working with contract resources may find it challenging to determine where to begin.  Consequently, it is helpful to view contract research organizations (CROs) in much the same way as consultants are viewed.  There is no one-size-fits-all formula and each situation will be different from the next.  In the following paragraphs, strategies relevant to the identification and efficient utilization of contract laboratories are presented.

How to find a contract research organization (CRO)

CROs are groups hired to perform specific tasks based upon corporate needs.  As with consultants, the best way to identify qualified CROs is through referrals.  Even in the absence of any experience working with CROs, simple personal endorsements of past performance goes a long way to establish confidence with potential contract vendors.  Such confidence is essential to the development of positive working relationships – especially when crossing cultural lines

How to determine if a CRO is the right CR

As with consultants, different CROs have different strengths.  Some may be best suited for small-scale work while others may have stronger competencies in large-scale manufacturing.  Some may be strong in peptide synthesis while others may have expertise with carbohydrates.  Some may be able to prepare compounds utilizing standard organic chemistry techniques while others may have strengths in automated and solid-supported methods

When evaluating CROs, it is essential to be able to match corporate needs with the technical capabilities of prospective vendor labs.  Reliance upon a single CRO for all purposes is never advised.  Finally, those seeking the services of a CRO should seek competitive bids from several organizations.  If the technological expertise, cost and timeline all fit within project needs and budgets, the right CRO has been found

What country is best for outsourcing

Where to send work is largely a matter of where one is comfortable sending work.  Most chemists working at offshore CROs have adequate technical skills and can accomplish most any task with proper supervision.  The real issue is how well a given company can interface with a given oversea culture.  These days, language is not much of an issue as most team leaders speak English.  If cost is a concern, China and India based CROs are among the least expensive.  European CROs are more expensive and the highest costs for services are found in North America

How is intellectual property protected

In any outsourced relationship, there is the risk that technology and/or prepared materials will be inappropriately shared or utilized.  While confidentiality within the United States is easier to enforce, there can never be a guarantee of complete compliance.  Therefore, the less information provided to a CRO, the better intellectual property will be protected.  In general it is good practice to separate compounds and structures from associated biological activities.  Furthermore, it is also good practice not to share the intended use of target structures.  Through this “firewall”, collaborating CROs will be unable to study or apply target structures in competing programs and intellectual property will be safeguarded

How is workplace efficiency measured when hiring contract labs

Workplace efficiency is virtually impossible to gauge without direct supervision.  Unfortunately, when working with offshore CROs, frequent site visits will rapidly diminish any perceived cost benefits.  This leaves a potential vacuum of interactive oversight typical of how in-house productivity metrics are measured.  In order to address this challenge, companies interested in engaging the services of contract organizations typically recruit experienced CRO managers.  Such managers may be in-house employees or consultants.  However, in all cases, qualified CRO managers typically have many years of experience working with CROs.  Additionally, they typically have established relationships with multiple vendors providing complementary services.  Through this experience, qualified CRO managers are able to maintain efficiency, troubleshoot and gauge progress – even when communicating across continents

In summary, today’s cash constrained industrial climate has resulted in a reality where experience in life sciences does not guarantee employment.  As more traditional pharmaceutical paradigms give way to decentralized and virtual organizations, more research is being redirected to the talents of contract scientists serving from various established and emerging economies.  Successful engagement of these contract resources requires the following:

  • Experience in the science being outsourced.
  • Experience in managing outsourced services.
  • Established relationships with CROs in preferred geographic regions.

Through the skills of individuals having this experience, engagement of CROs can be quickly accomplished with rapid program initiation and minimized risk.

 

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