How Mid-sized & Emerging Biopharma Sponsors Can Choose Clinical Trial Technology For Their Needs

Insights from Medidata Experts

Mid-sized and emerging biopharma companies drive innovation in clinical trials, and their choice of technology plays a critical role in powering this innovation. How can mid-sized and emerging sponsors leverage technology and data to best position themselves for success?

This two-part blog series, following a post on general recommendations, brings insights from Medidata’s experts who have worked with more than 1,200 mid-sized and emerging sponsors on how to leverage proven innovative technology to succeed.

Data Access, Oversight, and Scale

Choosing technology that allows mid-sized and emerging sponsors access to their data in real-time largely determines the success of their trials. Real-time data oversight provides sponsors with key trial information, allowing them to make informed decisions and make study changes as they go, saving time and money. Legacy data is also becoming increasingly valuable for sponsors to draw more insights and make better decisions about next steps. Successful mid-sized and emerging biopharma companies have conversations with their CROs early on, outlining expectations regarding data access and oversight.

Sponsors enjoy multiple benefits when they are able to access their data when and how they need it. This mitigates risk in the case of working with multiple CROs and offers mobility and cost savings when scaling. Technology that allows this kind of data access supports growing sponsors.

These considerations help mid-sized and emerging sponsors identify a tech provider that ensures access to data during, as well as after, study completion for future references.

When to Start Evaluating Technology

For many mid-sized and emerging biopharma companies, technology is usually an afterthought and occurs after CRO selection. This can limit certain technology capabilities that would otherwise facilitate the study planning process. There are various advantages of thinking about technology earlier on in the process. Developing a technology strategy at the outset informs trial design by giving sponsors awareness of their capabilities before building a protocol. For example, in some cases, a sponsor may need more than three months to implement an ePRO build, but that time would be omitted from an original timeline if the biopharma company did not consult the tech provider early in the planning process.

Evaluating technology early on helps mid-sized and emerging biopharma companies keep studies on time by allowing early planning and proactive identification of trial roadblocks. Working with tech providers early in the trial process also allows emerging and mid-sized biopharma companies to devise more patient-centric trials, an increasingly important feature to demonstrate long-term efficacy of a drug. Successful sponsors develop technology strategies before selecting a CRO or devising a study design. Sponsors that make informed technology decisions do so by understanding what technology is available before the planning process and researching multiple options. With a full understanding of available technology, sponsors express technology preferences to CROs during the process of CRO selection.

Unified Platform vs. Disparate Systems

Using disparate technologies to manage study data consumes time and money for mid-sized and emerging biopharma companies. While custom integrations are possible, they might compromise a few key attributes for sponsors, including:

• Data integrity: Integration with multiple vendors can expose emerging sponsors to data errors which might impact trial outcomes. Data errors are a hidden cost of data integration — it could compromise the data integrity needed to prove or disprove the study hypothesis.
• Data oversight: Integrations can prevent sponsors from accessing their data in real-time, a natural consequence of pulling data from disparate locations. This creates a reporting issue and puts sponsors at risk of making decisions based on insufficient data.
• Flexibility to protocol changes: Study protocols often change when adjustments are made as the study is live. This downtime to implement protocol changes can result in significant time delays for sponsors.

A unified platform alleviates the issues above by:

• Providing mid-sized and emerging sponsors with accurate data with no import or data failures, allowing sponsors to maintain data integrity.
• Providing sponsors with real-time oversight, allowing them to make informed decisions in real-time.
• Allowing for any changes to be reflected across all data instances and for intermittent protocol or data changes with no downtime to implement.

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.