Life Science Leader Magazine Supplements

CRO Supplement 2015

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BEST PRACTICES outsourcing THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 30 mall sponsors are faced with unique challenges, including smaller-scale trials, limited budgets, fewer personnel, and small pipelines that depend on the suc- cess of the lead program. Small sponsors must compete with companies that have multiple programs and trials, more robust budgets, and large in-house teams all vying for top-quality resources from CROs and other vendors. Most life sciences companies will elect to outsource at some point, so how does a small sponsor go about finding a vendor that is right for them? Through our work with dozens of small sponsors, we have refined several approaches to support selection of the right high-quality vendor. THE CHALLENGES AND NEEDS OF SMALL SPONSORS WHEN WORKING WITH CROs AND VENDORS Small sponsors have different constraints when outsourcing. They have limited employees wearing many hats who may not be expert vendor managers. Some of these companies may even lack people or processes to select and qualify vendors. Decision making is critical for any compa- ny, but for a small sponsor, every decision can feel like it's a make-or-break choice for the company — a wrong vendor decision could have future implications for the company's success or failure. Often there are executives from the company involved who are new to the nuances of clinical development, but because the decision is so pivotal, will insist on being involved at all stages. This adds complexity and must be recognized and accommodated by all parties, and there often needs to be exec- utive-level involvement by the CRO from day one. The funding available to small sponsors is often sparse, tightly budgeted, or unpredictable, and every dollar must be carefully managed. 3 KEY STEPS FOR VENDOR SELECTION We have found an effective process that works when it comes to selecting the best vendor for a small sponsor company. All involved must first agree on three key things: the process used for selection the criteria to select the vendor the decision of who has input and who makes the final determination Making decisions around these key pieces in advance of starting the vendor selec- tion process may seem both obvious and tedious, but doing so will help to lay the groundwork for successful management of a high-quality process. The Process Selection should start with identification of qualified vendors — a complex task even for veterans. Although we have a wide net- work of CROs and vendors with whom we've worked, the landscape changes and evolves constantly so we still make a point to reach out to our colleagues for timely referrals or recommendations. Vendors and teams change quickly in this indus- try so it's best to have up-to-date reviews across multiple sources. Once a list of potential vendors is compiled, the rest of the traditional process applies: request for proposal (RFP), proposal review and anal- ysis period (with open and honest com- munication), bid defense meetings, due diligence capabilities audits, negotiation, scope work, final selection, and transfer of obligations. The most critical but subjec- tive goal at this stage is to identify a short list with the right fit from both a scale and cultural perspective. The Criteria In order to swiftly move through the vendor selection process, the team must agree on the selection criteria before the process begins. This must be managed within the sponsor team and clear expec- tations aligned internally before focusing outwards. Although the detailed criteria will be protocol-specific, CRO- and ven- dor-selection criteria should be based on three key areas: By K. McCarthy & C. Peterson VENDOR SELECTION FOR SMALL SPONSORS: AN APPROACH THAT WORKS S Vendor Selection For Small Sponsors: An Approach That Works K A T I E M C C A R T H Y & C O N N A C H T P E T E R S O N The number of small biotech and pharma companies continues to increase and, predictably, outsourcing across the industry is on the rise. Finding the right external vendor is a critical challenge for any sponsor company, and it can be especially challenging for a small sponsor.

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