The Power of Master Non-Disclosure Framework Agreements in Clinical Trials

Clinical trials in oncology are critical in advancing cancer research and developing innovative therapies that can improve patient outcomes. In the pursuit of ground-breaking advancements in oncology research, collaborations between CROs and Sites play a pivotal role. Key to enhancing such collaboration is the implementation of Master Non-Disclosure Framework Agreements (“Framework mNDAs” – also referred to as Master Agreements) by CRO partners with their Sponsors and Sites to foster successful partnerships while ensuring data security and confidentiality.

Framework mNDAs have significant benefits that combine to become a powerful tool to strengthen trust, foster efficient collaboration, ensure compliance with data protection regulations, and promote knowledge sharing while streamlining contractual arrangements. Furthermore, Framework mNDAs enhance the attractiveness of CROs to Sponsors and industry partners alike while providing vital risk mitigation and legal protection.

1. Strengthen Trust and Confidentiality

In the realm of clinical trials, trust and confidentiality are key tenets of any relationship. A Framework mNDA establishes a foundation of trust between the CRO and the Site, as it lays out the terms and conditions for maintaining the confidentiality of sensitive information, especially as it pertains to a particular Sponsor’s trial. By ensuring that all parties involved are committed to safeguarding proprietary data, the Framework mNDA mitigates the risk of unauthorized access, disclosure, or misuse, promoting a secure and collaborative research environment.

2. Efficient Collaboration and Timely Clinical Trial Initiation

Framework mNDAs streamline the collaboration process between the CRO and Sites. By addressing confidentiality concerns at the outset, researchers can focus on collaborating, exchanging insights, and jointly analyzing information and data without fear of compromising proprietary information. Furthermore, by providing a comprehensive framework for confidentiality across multiple sponsored clinical trials, the Framework mNDA reduces the administrative burden associated with negotiating separate confidentiality agreements for each clinical trial. This efficiency allows i) Sites to decide quickly about whether to run a particular clinical trial – i.e., information required to facilitate early conversations about general feasibility can occur early-on, allowing the Site to progress to Site Selection sooner – meaning that promising oncology treatments can reach patients in a timelier manner; and ii) Sponsors and CROs to reduce timelines associated with clinical trial initiation.

3. Streamlined Contractual Arrangements

The complexity of clinical trials demands a number of different contracts and agreements, which can prolong clinical trial start-up for all parties. By adopting a Framework mNDA, the CRO and Sites can at least streamline contractual arrangements related to confidentiality.

The Framework mNDA serves as a foundational document, with subsequent trial-specific appendices incorporating its terms and conditions by reference. The NHS Research and Development Forum found that experienced contracts teams reported an increased burden of managing an increasing number and variety of confidentiality agreements. Increasing backlogs and demanding workloads of site contract teams has become too onerous and has negatively impacted the efficiency of trial start-up in many cases.

Such delay can cost a clinical trial Sponsor millions of dollars in lost opportunity, given the finite period of a drug patent life cycle. Therefore, streamlining agreements via a Framework mNDA, expedites contract negotiations, preventing lengthy delay, and can save valuable time and resources for all parties involved.

4. Risk Mitigation, Legal Protection, and Compliance with Data Protection Regulations

Clinical trials inherently carry certain risks, including the potential for confidentiality breaches. A Framework mNDA helps mitigate these risks by outlining the responsibilities and obligations of each party in preserving confidentiality. By clearly defining the consequences of non-compliance, the Framework mNDA serves as a safeguard against potential disputes and legal liabilities. Additionally, data protection regulations are becoming increasingly stringent in the medical research domain. A Framework mNDA ensures that the parties involved in clinical trials adhere to the highest standards of data protection and comply with relevant privacy laws specific to any particular region. This proactive approach to compliance not only reduces legal risks but also fosters trust in the research process.

5. How Scimega Leverages Framework mNDAs

Sponsors prioritize data security and confidentiality when selecting research partners. Seeking out CROs with a Framework mNDA in place with Sites can significantly enhance their time to trial start-up. As an example, at Scimega, a Canadian niche oncology CRO that serves medium size and smaller biotech companies conducting oncology research in Canada, Framework mNDAs are in place with sites, in each of the 10 provinces.

Not only does this provide Scimega’s Sponsors a broad and diverse range of access to sites for trials, but the existence of a Framework mNDA demonstrates a strong relationship with such sites and a commitment to protecting proprietary information, making this particular CRO more attractive for Sponsors and other stakeholders invested in advancing oncology research for trials conducted in Canada.

6. Why Scimega is the Right CRO Partner for You in Canada

The future success of an increasingly more complex clinical trials industry, including the ability to bring new products to market, rests on whether Sponsors and CROs are able to work effectively and efficiently with their network of Sites. All parties benefit from strong partnerships established based on common goals and objectives intended to result in win-win-win-win outcomes for Sponsors, CROs, and Sites, and patients.

To ensure the success of Sponsored Clinical Trials in Oncology in Canada, the Scimega team considers the implementation of Framework mNDAs essential. These agreements strengthen trust, foster efficient collaboration, ensure compliance with data protection regulations, and promote knowledge sharing while streamlining contractual arrangements. Furthermore, by embracing the power of Framework mNDAs, Scimega contributes to the Canadian oncology research community’s capacity to propel medical innovation at home, and ultimately improve the lives of cancer patients worldwide.

Scimega is uniquely positioned, and our relationships with sites are well-established to efficiently manage site contract process for Clinical Trials in Oncology. Moreover, our contract negotiation capabilities span over our 25 years of business in Canada, making this niche Canadian oncology CRO well-equipped to protect the rights and needs of both Sponsors and Sites alike.

The Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies. Scimega selected and motivated Canadian sites consistently surpass FPI targets, and over 90% of active sites enroll participants.

Contributed by: Chantalle Willie, Feasibility Manager

References:
NHS Research and Development Forum (https://rdforum.nhs.uk/)
Drivers of Start-Up Delays in Global Randomized Clinical Trials; Therapeutic Innovation & Regulatory Science (https://link.springer.com/article/10.1007/s43441-020-00207-2)