In just a few short days, UBC will be meeting with manufacturer sponsors at Partnerships in Clinical Trials 2013. We look forward to collaborating with you and sharing insights we’ve learned through successfully developing, implementing, and supporting many of the industry’s largest, most complex global research programs.
Manufacturers are faced with significant internal capacity constraints, resulting in increased pressure to conduct their clinical trials in the most efficient and cost-effective manner possible. As such, service providers may be chosen based only with efficiencies and aggressive study timelines in mind. Experience tells us to consider ALL of your study goals prior to selecting a provider and launching your study. Here are a few guidelines that can help manufacturers create a successful partnership with service providers:
- All manufacturer and service provider relationships should have a senior level of management representative who is actively involved in the relationship. Feedback we’ve received from manufacturers tells us this dedication is imperative to allow for rapid decision making. When escalation is necessary, manufacturers have direct access to the senior staff person, avoiding the need to work through several layers within the service organization to reach a decision or resolution.
- Manufacturers and providers should integrate goals and objectives at the conception of each relationship to discuss expectations as well as roles and responsibilities. This allows both parties to obtain clarification of any areas of uncertainty prior to study launch.
- Clearly identify which processes and systems are to be used. While a “hands off” approach by the manufacturer allows the service provider to use their own processes, enabling rapid transitions, and decreasing time spent educating staff, some manufacturers prefer that their processes and systems be used. In these cases, a strong infrastructure to support these relationships is necessary, including a dedicated trainer assigned to the project. This trainer works with the project team to ensure training is completed in a timely manner as well as to ensure compliance with any updates during the course of the study. The trainer also serves as the subject matter expert on the manufacturer’s systems. This approach has allowed UBC project managers to focus on managing the studies and ensuring a proper and timely launch, rather than focusing time and effort on staff training and comprehension of the client’s processes and system requirements.
- Access to the industry’s leading scientific experts is key to forming a successful relationship. The experience and knowledge of a renowned and educated staff of scientists and medical doctors enables project teams to have key resources available to them when needed. UBC project teams have relied on these expert staff resources for protocol input as well as assistance with problem solving. Clients have recognized us for this innovative approach which has allowed for much more creativity and demonstrated a proactive approach.
- Discuss expectations at the inception of the relationship. This provides clarity to both the manufacturer and service provider on whether to follow the manufacturer’s standard operating procedures (SOPs) or those of the service provider, which systems will be utilized, and what decisions are to be made without the manufacturer’s input.
- Learn as much as you need to about your service provider to establish confidence and trust in them. This allows the provider to function independently and liaise with the manufacturer for purposes of providing study status updates, problem solving, and decision making.
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