The increasing globalization of R&D over the last several decades have made it challenging for pharmaceutical companies to operate with in-house teams alone. The practice of clinical outsourcing is on the rise as a way to reduce operational and infrastructure costs, increase clinical timelines and organizational agility, and achieve scalable growth.
To realize the benefits of this outsourcing model, sponsors and CROs must form an effective collaborative relationship with transparent communications in an environment based on trust. Collaborative relationships between sponsors and CROs have the potential to deliver savings in both time and money, increased patient safety, improved regulatory compliance, and enhanced trial data quality.
This collaborative environment is not necessarily easy to create. A sponsor's involvement in clinical trials that are very specialized in nature, and the need for multiple CRO partners to manage large pipelines, inevitably results in a complex operating environment.
Sponsors are generally seeking to reduce costs, access specialized knowledge, decrease clinical timelines and increase operational agility. CROs, on the other hand, need partnerships with multiple sponsors to remain economically viable, focusing on business goals related to economic success for their owners, investors and shareholders. As all sponsors and CROs have different goals, processes, and culture, creating an effective collaborative environment with conflicting stakeholder interests is challenging.
Although some sponsors have taken steps to create a more collaborative environment with CRO partners, many still perpetuate a client/vendor mentality at both the operational and management levels that tends to perpetuate a lack of trust and empowerment in CROs, ultimately leading to frustration for both parties. Their interactions typically have been fraught with inefficiencies and needless duplication of task ownership.
Collaborative efforts generally involve initiatives such as shared decision making, delivery of broad cross-study solutions, performance assessments, and shared risk and reward structures. The goal is for the partners to operate as a team where both parties benefit. Let's detail some of the best practices to ensure a successful sponsor-CRO collaboration.
Tips for successful collaborations
- Learn Each Other's Language and Culture. Increasing globalization necessitates that both sponsor and CRO perform due diligence in learning each other's "language" and culture in order to foster collaboration and trust.
- Establish Joint, Multi-level Governance of Study Activities. Collaboratively establish a common vision and understanding of the partnership. Develop goals and metrics that measure alignment with and performance against the shared vision of both partners.
- Establish a Mutually Agreed Upon and Practical Communication Plan. To avoid communication breakdown, have a centralized and practical communication plan in place with escalation procedures on both sides at all levels. Define what kind of communication is expected during the study, and what event(s) trigger an escalation.
- Develop and Maintain a Study/Site Risk Assessment Plan. Sponsors and CROs should work together to identify potential risks and design risk mitigation actions in advance where possible. Ongoing risk assessments should be performed on both the site and the study itself to assure data quality and prevent problems.
- Define Business Processes, Including Roles and Responsibilities. Both study sponsor and CRO have defined business process and systems in place for elements of the study lifecycle, and both will need to adapt to form an effective partnership. Make sure everyone on both teams understands the overall study processes and what their role is.
- Establish Key Performance Indicators (KPIs) for Partners and Study Deliverables. In order to be meaningful and effective, KPIs need to be created collaboratively and align with incentives for both partners. Team members from both sponsor and CRO must understand how study progress is being measured and why.
- Determine How KPIs Will Be Monitored and Addressed When Deficient. What is the level of transparency and accessibility needed to effectively monitor KPIs, and what is the team going to do if there is a problem?
- Align Team Goals with Business Goals Across the Partnership. The business goals of both the sponsor and CRO need to be taken into account when defining team goals.
- Invest in Software Tools that Enable Communication, Management, and Automation of Activities. Cloud-based platforms that enable immediate data sharing across partners are ideal for this purpose.
- Treat Study Team Members as One Cohesive Unit, Regardless of the Organization. Allow CRO partners to have a say in things like protocol design, monitoring plan, and data management practices. Develop incentives to motivate team members to support both short-term study and long-term partnership expectations.
- Create an Atmosphere of Positive Collaboration and Continuous Improvement. Effective collaboration requires two-way communication and transparency. Put in place mechanisms to enable two-way communication and feedback between CROs and sponsors in order to ensure the success of the study.
The success of the life science industry in bringing new products to market in the era of outsourcing clinical trials rests, to a large extent, on the ability of sponsors and CROs to work together successfully in a collaborative partnership. This partnership must operate with open and transparent communications that foster a foundation of trust and mutual commitment.
Getting the process right is only one aspect to consider, however, equally important is implementing the right technology tools to support process transparency, data sharing, and communications across company lines. Ultimately, speeding the delivery of life-saving therapies to patients and disrupting the client/vendor 'status-quo' mindset.