How Mid-Sized Biopharma Sponsors Can Leverage Medidata’s Clinical Trial Technology and Expertise
How Mid-Sized and Emerging Sponsors can Leverage Medidata’s Clinical Trial Technology and Expertise to Succeed
Insights from Medidata Experts
Mid-sized and emerging biopharma companies drive innovation in clinical trials, originating and launching 40% of new active substances (NAS) in 2020.1 However, lean resources, limited access to sites and patients, lack of integrated systems, and uncertain funding impose restrictions on mid-sized and emerging sponsors and slow the pace of drug development.
How do sponsors position themselves to succeed and overcome challenges? This two-part blog series, followed by a post on technology, brings insights from Medidata’s experts who have worked with more than 1,200 mid-sized and emerging sponsors on how to leverage the technology and expertise to succeed.
Addressing common obstacles
Medidata experts have observed three key obstacles that commonly affect emerging companies: budget issues, failure to meet critical endpoints, and data access issues. Unanticipated costs arise as a common issue because clinical development and CRO costs can eat up a sponsor’s entire budget. To plan for these cost changes and mitigate the budget and study delay risks, mid-sized and emerging sponsors can compare price quotes from multiple companies, look for vendors that provide cost flexibility, and have open conversations with vendors about needs and pricing expectations.
Failing to meet critical endpoints, such as not collecting enough study data or recruiting enough patients, delays studies and significantly impacts outcomes. To prevent any endpoint failures, sponsors can invest in EDC systems connected to a unified platform, which prevents issues with clinical data management and collection, allowing real-time data oversight and error correction. Also, consulting site performance data, including patient recruitment compared to industry benchmarks, helps sponsors make better site selection decisions and negotiate for lower costs.
Outsourcing to CROs, a common practice among mid-sized and emerging sponsors, can complicate remediation of any last-minute issues. Successful sponsors have open conversations with CROs early on about data access to maintain visibility into the crucial study information they need to resolve issues and execute a successful trial.
Regulatory approvals require experience and manpower, especially for novel drugs with no clear path to approval. Foresight into the approval process helps mid-sized and emerging sponsors successfully navigate it. Equipped with insights from experienced technology providers into what aspects of a study regulators commonly push back on, sponsors can proactively address issues and avoid delays in the approval process.
Regulatory bodies commonly request adjustments to a study before the study even begins. To avoid added costs and study delays from these types of changes, we recommend mid-sized and emerging sponsors build relationships with regulators as early as possible to understand their thought processes.
Mid-sized and emerging sponsors often struggle with cost predictability, especially before a study starts. Successful sponsors spend time designing efficient protocols, but even small protocol amendments can incur significant costs increases. While inexpensive technology solutions may seem appealing to sponsors with tight budgets, rigid price models can be less forgiving to protocol changes and ultimately lead to much higher costs. Instead, flexible pricing models might better accommodate protocol changes and study fluctuations. To gauge more accurate cost estimates and avoid last-minute cost escalations, successful mid-sized and emerging sponsors research costs for various trial scenarios, set aside additional funds for unexpected costs, and have conversations with technology vendors early in the process.
Medidata’s 20+ years of expertise, dedicated support, and continuous learning with customers and trials of all sizes help you stay on the path to success. Mitigate risk by managing your data and workflows in one place with proven innovative technology supported by a trusted partner at the center of the life sciences ecosystem. Together with your CRO, we can achieve our collective mission of extending greater value to patients and realizing the best possible outcome of trials. Learn more about recommendations and solutions we offer to mid-sized and emerging sponsors here.