Innovating at Unprecedented Pace
COVID-19 prompted dramatic changes in the way we conduct research. In the months since the pandemic began, we have completed literally thousands of fully remote consumer data collection interactions for OTC switch and other programs. To make these studies flow seamlessly, we are now taking even more steps to strengthen our “decentralized” model and expand research offerings for clients.
Finding and Engaging Difficult-to-Reach Subjects
As studies become less about site location and more about engaging consumers wherever they work and live, recruitment naturally evolves in fundamental ways:
- PEGUS is aggressively expanding digital (social media) recruiting modalities and online self-screening, as well as innovative methods to capture difficult-to-reach groups, like adolescents. These tools are increasingly critical as consumer research focuses more on targeted sufferer groups and low-literacy.
- Sophisticated analytics at PEGUS help keep sponsors fully up-to-date and allow careful monitoring and optimization for each recruitment channel. We can fine-tune content and targeting mechanisms in near real time.
Fully Electronic Signatures
PEGUS has now adopted an industry leading, validated 21 CFR Part 11 compliant functionality as the foundation for electronic signatures on all site and sponsor documents, contracts, and internal study documentation. This reduces the time and cost of operationalizing research. Simultaneously, our subject-facing data collection solutions capture fully-compliant electronic signatures from subjects on informed consent forms, permissions, acknowledgements, and other agreements.
New Subject-Facing Data Collection Tools
In addition to robust EDC capabilities, PEGUS has expanded the scope of subject-facing data collection solutions to include new eDiary, ePRO, and eConsent functionalities. These platforms:
- Integrate and simplify the user experience across visits and assessments
- Reduce the need for data hand-offs between systems.
Paper TMFs Are a Thing of the Past
Paper trial master files are rapidly becoming obsolete. PEGUS will implement a new validated, Part 11 compliant eTMF system in February 2021. The new eTMF platform provides a comprehensive electronic repository for study and quality documents that is designed to be perpetually audit-ready and easy to transfer to sponsors. It also includes new electronic quality and training (eQMS) functions.
New Investigational Product (IP) Storage and Distribution Capabilities
PEGUS has also invested heavily in new infrastructure to manage and distribute IP on behalf of sponsors, which is particularly important for decentralized clinical studies. This greatly improves efficiency, reduces overall cost and represents one more way PEGUS provides “one stop shopping” to its sponsors.
Innovative Research Designs
New technologies and rapidly evolving methods have allowed PEGUS to expand offerings in the following areas:
- Real World Evidence (RWE) Studies: PEGUS has developed unique capabilities to prospectively enroll and follow actual Rx or OTC users in their existing real-world environments. We also collect data directly from HCPs on prescribing and treatment practices. These studies may be purely descriptive to answer specific regulatory questions, or may provide concurrent, real-world context or control to benchmark results from consumer behavior studies.
- In-Home Patient-Reported Efficacy Trials: These unique, randomized (placebo-controlled or head-to-head), patient-reported outcome studies generate safety and effectiveness data to support new claims.
- Rx Label Comprehension: PEGUS helps clients test comprehension for medication guides and other prescription labeling to address postmarketing and other requirements like REMS (risk evaluation and mitigation strategies).
- International Consumer Research: Our skill with executing remote data collection also positions PEGUS to efficiently support clients’ research programs outside the United States.
Constancy Amid Change – PEGUS Core Values Hold Steady
During this rapid paradigm shift (from in-person to fully remote research), we haven’t forgotten who we are. PEGUS is tirelessly focused on responding to the dynamic needs of our clients and developing science and methods to intelligently anticipate regulatory requirements. We are true innovators in successful decentralized research while carefully ensuring scientific robustness, the safety and wellbeing of participants, and the rigor, integrity, and regulatory acceptability of study data.