Outsourcing Clinical Development: Strategies for Working with CROs and Other Partners
From the CRO end, a clear understanding of the priorities allows appropriate resources to be allocated and projects to be delivered with efficiency. In practice, however, it takes time to harmonize companies' cultures and put each and every collaborator on the same page.
FSP Or Full-Service Outsourcing For Clinical Trials
For each side, there is a learning curve to be followed, which can be achieved faster with an experienced and open leadership team from both sides of the partnership. It is a long way until reaching a healthy and mature relationship, so building trust between all the parts and a culture of partnership are the fastest way to succeed through the process. More and more outsourcing opportunities will certainly be seen in the next years, not only to specific study activities, such as data management, central lab processing, monitoring, but also for a broader range of business possibilities.
It can be a storm to align both parts expectations and interests. On one hand it may bring a lot more operational difficulties as more layers lay between trials decision making, contracts and payments stress, high turnaround of CRAs, longer time to provide answers to the sites and even Investigators relationship being affected with sponsors. On the other hand, the outsourcing allows a more holistic approach as it permits a different management focus to the sponsors and sites. An additional oversight to the study quality can be implemented, environment shaping with regulators and other stakeholders, dedicated personnel to support the development of clinical research sites and even integration between pharmaceutical companies in order to develop systems that facilitate site activities and information exchange.
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- Outsourcing Clinical Development: Strategies for Working with CROs and Other Partners.
He or she, by and large, lost the business. Internal resources in pharma are now extremely limited, even when the Functional Service Provider model is used. In many cases, the global alliances with CROs took from the local medical area the power to influence clinical research activities in the country. The responsibility for nurturing a relationship with investigators was transferred to a new growing professional job, the Medical Science Liaisons MSL.
The CRO has by and large taken over the decisions and communication with global study teams. The positive aspect for the internal pharma resources that remained is a more globalized relationship with peers with active experience exchanges, less hierarchical layers with more individual exposure and visibility. Also, working in different global initiatives with cross-functional teams empowered individuals to be involved in different scenarios for problem-solving. All in all, despite the difficulties posed by the partnership, new and different careers were developed in parallel, for personnel from both pharma and CROs.
With 13 years of experience in clinical development in Pharma, working closely with CROs and Sites development. Eduardo F. He has over 25 years of experience in big pharma and CROs, working in clinical development and clinical operations roles in Brazil and Latin America.
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Thursday, May 28, Operating clinical trials at a global scale can be a daunting task. The pharmaceutical industry has relied heavily on outsourcing to reduce costs and shorten development timelines. To this end, selecting a CRO has become extremely critical to the success of an entire study.
Building Strategic Sponsor-CRO Partnerships
In recent years, the industry has witnessed a number of strategic partnerships formed between global pharmaceutical companies and global CROs to streamline clinical development processes. At present, sponsor-CRO relationships comprise a combination of tactical, preferred provider and strategic partner relationships. For CROs, becoming a strategic partner is a gradual evolvement from tactical service provider status. A successful strategic partnership is mutually beneficial, requiring commitment from both parties to work together as a united team with integrated goals, structure and processes.
It is important to clarify expectations, responsibilities, commitments and investments for each party at the very beginning of the partnership. Additionally, a governance structure is fundamental for communication, collaboration, escalation and risk management that enables the sponsor and CRO to function as an integrated team. Another key element for a successful strategic partnership lies in effective, open communication that promotes a high degree of cross-organizational transparency and information sharing.
Keep up with our latest articles, news and events. Cultural Fit Start the vetting process for an FSP relationship with a CRO by asking about company values, how conflicts are resolved, communication channels, management oversight, and approach to customer service. Experienced CROs also will have recommendations for training programs, which will ensure a seamless integration between CRO and sponsor staff as well as ensure new staff members are trained quickly and efficiently. Ask if the company has suggestions for the best way to work together, including overall program management, rapid start-up processes, points of contact, system usage, process development, deliverable and timeline tracking, and billing.
Consistency Sponsors should ask potential CRO partners about company and team turnover rates. These strategies should be part of the foundation of the FSP partnership. Flexibility and Scalability Sponsors should ask the CROs how they plan for and handle the need to scale up quickly, as well as how they avoid underutilizing resources. In both cases, some sort of strategic forecasting and proactive communication should be part of the plan. Program governance meetings are an excellent strategy for managing the resourcing demands of a successful FSP partnership.
These meetings can occur as often as necessary to ensure constant communication between CRO and sponsor. Both parties should contribute to the agenda to ensure active engagement and bidirectional communication.