How Technology Decisions Impact Success for Emerging Biopharmas and Biotechs
Emerging biopharma and biotech (EBP) companies drive innovation in clinical trials, and the choice of technology plays a critical role in powering this innovation. How can EBPs leverage technology and data to best position themselves for success? Medidata consulted with internal experts who have worked with thousands of EBPs and have insiders’ perspectives on how to avoid study pitfalls and stay on the path to success.
This article is part two of a two-part blog series, following a post on general recommendations for EBPs. This post further explores specific recommendations for technology.
Data access, oversight, and scale
Choosing technology that allows EBPs access to their data in real-time largely determines the success of their trials. Real-time data oversight provides EBPs 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 EBPs have conversations with their CROs early on and outline expectations regarding data access and oversight.
EBPs 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 such data access supports growing sponsors.
These considerations help EBPs 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 EBPs, 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 EBPs awareness of their capabilities before building a protocol. For example, in some cases, an EBP may need more than three months to implement an ePRO build, but those three months would be omitted from an original timeline if the EBP did not consult the tech provider early in the planning process.
Evaluating technology early on helps EBPs 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 EBPs to devise more patient-centric trials, an increasingly important feature to demonstrate long-term efficacy of a drug. Successful EBPs develop technology strategies before selecting a CRO or devising study design. EBPs 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, EBPs 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 budget for EBPs. While custom integrations are possible, they might compromise a few key attributes for EBPs, including:
- Data integrity: Integration with multiple vendors can expose EBPs 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 EBPs 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 EBPs.
A unified platform alleviates the issues above by:
- Providing EBPs 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
Considering those benefits, Medidata’s experts recommend that EBPs consider technology that ensures data ownership and integrity, which ultimately allows flexibility to adapt to protocol changes.