Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner

A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts to partner with and seek advice throughout the clinical development process allows researchers to focus on what matters most: bringing therapeutics and devices to market safer and faster. This blog outlines five benefits of engaging with an expert partner for biopharmaceutical and medical technology companies.

Freeing Up Internal Resources

Many small to medium-size biopharmaceutical and medical device research teams have limited bandwidth, resources, and funding. It’s imperative for these organizations to find a partner to support them through the difficult and time-consuming components of the clinical development process. Partnering with an external organization to fill in staffing discrepancies, improve processes, and assist with site selection makes all the difference in streamlining study activation. Obtaining details on sites’ past performance and capabilities, such as therapeutic area, indication, location, and enrollment rates, helps you identify high-performing sites more easily. Seeking support in protocol design and feasibility can also free up internal resources and help speed the review process by ensuring regulatory and safety requirements are appropriately addressed, thus minimizing follow-up questions from the review committee. Utilizing these extra resources can increase research productivity, maximize your return on investment, reduce administrative burden, and ensure compliance.

Accelerating Timelines

Speeding clinical development timelines is always a priority, even for complex trials. For example, biopharmaceutical and medical technology companies are currently innovating cell and gene therapy research, which involves genetically engineered treatments and vaccines. Recent COVID-19 vaccines have brought attention to mRNA technologies in particular. This segment of the industry is growing rapidly and shows no sign of slowing. In many cases, studies involving cell and gene therapies require institutional review board (IRB) and institutional biosafety committee (IBC) review. While sites can receive approval from separate IRBs and IBCs, it is beneficial to consider a combined approach. Working with an integrated, central IRB and IBC can save weeks or even months off a study activation timeline, keeping the protocol on schedule and helping ensure safe, compliant research conduct.

Data Protection and Analysis

With technology being an increasingly integral element in research, being 21 CFR Part 11 compliant is equally critical to an organization. However, many are unaware of this requirement. Certain clinical trial management systems, mHealth mobile applications, and site and protocol training systems are subject to 21 CFR Part 11. Identifying a partner to rigorously inspect and reveal any gaps in compliance, proactively identifying and mitigating risks to help your organization avoid an FDA inspection citation or a possible halt in operations.

Additionally, you can further accelerate startup by finding a partner who can provide site identification and feasibility support with reliable and customizable performance metrics.

Compliance

The complexities involved in biopharmaceutical or medical device research require a diligent and comprehensive approach to quality assurance. As the national and international regulatory landscapes are ever-changing, it may be difficult to keep up with what is current and required. Partnering with research compliance experts helps sites and sponsors navigate the regulatory environment, ensuring compliant and high-quality clinical study conduct.

Increasing Site Engagement and Participant Retention

Participants who have a positive research experience are more likely to stay involved throughout the entire study. By engaging and supporting their sites, sponsors empower site staff to deliver that positive experience.

Biopharmaceutical and medical technology companies should embrace new technologies to build deeper engagement with participants and sites and make it easy to adapt to evolving regulatory demands. To ensure a successful trial, it is important to identify a clinical trial platform to keep your sites involved, identify risks, track communications, pre-screen participants, and engage patients.

Whether it’s for clinical development planning, study startup, site activation, or overall compliance, Advarra is the trusted partner for small- to mid-sized biotechnology, pharmaceutical, and medical technology/device companies as they work to achieve their development objectives. Contact us today.

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