For many sponsors of clinical trials, particularly the smaller pharmaceutical, biotech, and medical device companies, as well as nonprofits and academic medical centers, outsourcing is a necessity. It often isn’t feasible or cost effective to conduct all clinical trial operations – from study design through submission – in house. For that reason, when it comes to partnering with a clinical research organization (CRO), study sponsors are faced with a crucial decision: whether to work with a one-stop-shop CRO or several specialty service providers.
There are pros and cons associated with both options, and the decision ultimately comes down to the trial’s requirements and the specific needs of the sponsor. Today, however, as the life sciences industry continues to evolve and innovate, the options for CRO engagement models are also changing. Strategic partnerships between small specialty CROs represent a new shift. By partnering with peers that offer complementary expertise, small CROs can expand their service offerings and take on more complex projects. For sponsors, the benefits of specialty CRO collaborations are significant, including greater efficiency, cost savings, and the ability to bring together the best minds in the industry to solve complex problems.
CROs Forge Partnerships to Bring Together Top Experts & Best-In-Class Capabilities
With complex trials focusing on increasingly sophisticated therapies, the right combination of expertise, solutions, and processes are necessities when outsourcing vital processes such as data management, programming, and statistics. Recognizing this, Bioforum and Veramed formed a strategic partnership combining their synergistic services and solutions, as well as their shared commitment to agility and quality.
Bioforum is a data-focused CRO with more than a decade of experience that supports clients worldwide in optimizing the collection, standardization, and reporting of clinical research data. Veramed, a people-focused CRO founded in 2012, specializes in providing programming and statistics services to clients across mid-stream, analysis and reporting, as well as post-reporting and submission stages of the clinical trial process. The two CROs initially began working together to support iOnctura, a Swiss biotech developing a novel immunotherapy for the treatment of cancer.
In addition to statistical programming, iOnctura, a long-term Veramed client, required clinical data management support for its complex trial and study structure. Recognizing that high-quality, well-prepared data might mean the difference between a successful regulatory submission and a frustratingly long approval process, Veramed sought out a boutique, data-focused CRO to provide additional support for the iOnctura study and immediately called upon Bioforum.
“Fulfilling biostatistics and programming needs for clinical trials often means working with large, full-service CROs that are unable to build the depth and breadth of knowledge these services require,” said Matt Jones, CEO, Veramed. “Small biotechs turn to us because they know that we have specialized expertise in the areas that offer them the best chance of success. We work by building trust, setting realistic expectations of what’s achievable, and then standing by those to deliver results.”
Jones added: “Bioforum shares the same values and, as a boutique CRO, works similarly on the data management front. Our partnership provides sponsors with highly specialized, best-in-class capabilities, and it provides both Bioforum and Veramed with the capabilities to expand our capacity and reach within the life sciences industry. It’s a win-win for all.”
Setting Up for Success
After Veramed introduced Bioforum to iOnctura, the two specialty CROs worked together to prepare proposals and budgets. Each company designated a team leader to help clearly delineate responsibilities and ensure the collaboration met established goals and agreed-upon project timelines. This close alignment between Bioforum and Veramed allowed for an efficient process and productive discussions with iOnctura, which ultimately resulted in the Swiss biotech’s decision to move forward with the proposal and a new partnership model.
“From our first interactions with the team at Veramed, it was clear that they share the same commitment to quality and focus on building trust that sustains long-term partnerships with clients,” said Amir Malka, Bioforum’s CEO and Co-Founder. “Together, we adopted a ‘one-team’ approach dedicated to agility and continuous improvement, avoiding unnecessary bureaucracy and establishing an open forum for communication that allowed our teams to share ideas and information that would support the study and our clients at iOnctura.”
With deep expertise in the process of gathering, validating, and preparing data for statistical analysis in clinical trials, Bioforum first set up a clinical database based on the study protocol and completed the build in an EDC within three months, meeting the agreed-upon milestones with iOnctura and Veramed. Next, Bioforum began the data validation process to ensure data accuracy and that all applicable global and local regulatory standards are met.
To provide actionable, risk-based insights and the timely and accurate review of clinical trial data, Bioforum has employed its in-house data visualization, anomaly detection, and trend identification tools, which are system agnostic. Ultimately, once the data is ready for analysis, Bioforum will oversee the database lock and the transfer of the datasets to Veramed’s statistics and programming teams for analysis.
Results that Matter
“We are pleased to be benefiting from the close collaborative relationship between Veramed and Bioforum,” said Catherine Pickering, CEO of iOnctura. “This new partnership has resulted in a close, synergistic working relationship which has optimized our clinical trial operations. Ultimately this will help our clinical compounds, roginolisib for uveal melanoma and IOA-289 for pancreatic cancer, transition towards the market.”
More broadly, successful partnerships like Bioforum and Veramed’s collaboration allow for customized solutions based on fresh perspectives, novel methodologies, and cutting-edge tools that foster innovation. As partners, specialty CROs can align their services with the unique needs and requirements of their clients, tailoring their approaches and strategies accordingly. This model also enables clinical trial sponsors to optimize how they manage their R&D budgets. Beyond cost savings, such flexibility to invest in support where it is most needed or will be most beneficial can help drive efficiency that results in shorter development timelines, faster regulatory approvals, and earlier market access.
“Bringing together highly skilled professionals who are dedicated to their respective areas of expertise ensures iOnctura gets focused knowledge targeted to its specific needs and that identified gaps are adequately addressed” Malka added. “In other words, as boutique, specialty CROs, we can be nimble and adaptable, which allows us to more easily explore innovative approaches and solutions.”