Outsourcing

Successfully Managing Your Study: Tips on How to Involve Your Vendor for Optimized Results

Outsourcing

09:00, November 1 2017

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Steven Kates, CSO & VP Regulatory Affairs, Lakewood Amedex, provides advice on how sponsors should manage their vendors

Whether you are in a large pharmaceutical company, a medium size biotech, or a semi-virtual/virtual company, whether it is in the drug, biologic or device space, the issues regarding working with an external vendor are similar. The issues spread to all areas of development of a product – medicinal chemistry, biological assays, ADME (absorption, distribution, metabolism, excretion), drug substance and drug product manufacturing, toxicology, and clinical trials (monitoring, data management, pharmacovigilance). 

An organization relies on the vendor to provide critical data that will be used in decision-making and development of the product. Thus, what can be done to manage your study more effectively and involve your vendor for optimized results? My perspective is based upon my years in virtual and semi-virtual small biotech companies (<20 people, currently at Lakewood Amedex), as a consultant to a CRO (ARIANNE Corporation), and as a faculty member at Northeastern University College of Professional Studies Regulatory Degree.

Outlining Responsibilities

The first is to clearly outline the responsibilities in a scope of work or work order (SOW/WO). For simple studies, such as routine biological assays or producing chemical structures, the process is straightforward. However, for clinical trials and supply agreements of commercial products, it is best to have legal counsel involved. It is important to remember that an SOW/WO is a contract that is legally binding. Thus, it is important to have the terms and responsibilities outlined and in writing. For small biotechs that do not have the luxury of in-house counsel, there are excellent firms, such as TriUnity Law Group that supply and customize templates for often-used contracts.

A communication plan is critical. Although there is payment for services, a sponsor needs to understand that the vendor cannot be at their beck and call. Unless it is specified in the SOW, sponsors need to be considerate of a vendor’s time. Additionally, the sponsor should provide a single point of contact to the vendor so that communication passes through consistently. It is also not critical to copy everyone on the thank you emails, etc. which just makes the email train laborious and less critical to review.

Building Strong Partnerships

Throughout the process, it’s essential to build strong partnerships at every level of the relationship. A successful outsourcing partnership involves senior leaders and managers, end users, members of the service delivery team, and other stakeholders. Show the vendor they are an extension of the company. Perhaps provide incentives for early delivery of timelines as well as discounts for missing key dates.

There are basic challenges related to conducting external studies especially when they are global. Cultural differences, including language barriers need to be discussed in sponsor project updates. Cultural conflicts can interfere with the development of a successful outsourcing partnership. It is important to carefully analyze the cultures of both organizations and develop action plans to engineer a successful collaboration.

This is extremely apparent in clinical trials in which the standard of care may be different. Establish a trust relationship, working as a team and encourage transparency. In addition, provide extensive training related to the study and study-related activities. This is important, especially once a vendor has come on board your project/study. For the sponsor, many times this is your job 24/7. What you think is obvious, is typically not obvious to a vendor who is managing multiple programs, technologies, etc. Thus, provide continuing support to the vendor’s staff and confirm they are satisfied with the information.

Manage Your Team

Many times, in an organization the sponsor’s employees feel slighted when the sponsor has decided to not conduct the work internally. It does not imply that upper management does not have the confidence in their employees; it’s a business decision that’s taken as what is believed best for the company. It’s important to understand the way people react to change. When major change comes to the workplace, people often experience fears and anxieties that create resistance.

If you carefully assess and address these causes of resistance, you can streamline the adaptation process and increase the pace of the transformation itself. As opposed to viewing the outsource as a threat, encourage team members that it brings new opportunities. Rather than focusing on technical aspects, sponsor team members can focus on risk management, crisis management, knowledge transfer management, and relationship management. These skills provide new opportunities for the sponsor’s employees to grow their skills more in business and strategy.

Start Slowly and Build Gradually

Finally, do not fall into the trap of being compelled to achieve an enormous return in the initial stages of the project. Begin small with a single, well-defined, self-contained pilot project that will minimize your initial risks and allow both the vendor and sponsor to acclimate to one another.

To conclude, regardless of the industry, technology and project scope, remember that a vendor is contracted to provide a service. You as the sponsor need to guide, encourage, and support their needs and requirements. Rather than using the old movie adage ‘show me the money,’ think ‘show me the data.’ Data-driven meetings and results are much better than speculating on speculations. As you never want to tell your upper management, you can’t handle the truth.

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