Parexel Insights

Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

05.16.22 - 4 min - Just because the COVID pandemic disrupted business operations, the importance of data integrity in manufacturing has not diminished. Accurate data is the foundation of product quality. How can sponsors reconcile the adaptations they made during the emergency with data quality assurance and regulatory expectations for compliance?

New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

05.10.22 - 6 min - Over the past decade, there has been a proliferation of real-world data (RWD) sources that sponsors can use to generate real-world evidence (RWE) for a wide range of purposes across the product development lifecycle. In addition to traditional claims and administrative data, they now have access to even higher-quality patient-level and regulatory-grade data generated by healthcare systems.

Patient Advocacy Groups: A vital partner for sponsors that understand how to engage with patients

05.03.22 - 4 min - Julie has spent more than 25 years advocating for patients with chronic diseases, both professionally and personally. She has extensive experience in recruiting, engaging, and retaining patients in clinical research. At Parexel, she focuses on engaging with patient advocacy groups (PAGs), patient communities, and social media influencers to improve the clinical trial experience for both patient and sponsor.

Patients as Partners 2022: Moving from Insights to Action

05.03.22 - 6 min - Empowered patients are the touchstone of modern healthcare. Yet, in a highly regulated industry, with scores of stakeholders, novel scientific questions and methodologies, emerging technologies and digital tools, the clinical research community can miss the forest for the trees when it comes to patient empowerment.

Toward more inclusive studies: Reaching and retaining patients from underrepresented communities

04.25.22 - 4 min - Across the clinical research community, we’re working toward creating more inclusive studies. By recruiting and supporting patients from underrepresented communities, we help ensure equitable access to clinical research opportunities. We also make our trials more comprehensive, giving us critical insight into a drug’s impact on a wider range of populations.

We are always available for a conversation.