Premier Insights

Clinical Research: Phase 1 - Phase 4

Premier Insight 281: Overcoming Enrollment Challenges in a Phase 2 Prostate Cancer Clinical Trial

Background Prostate cancer (PC) is among the most commonly diagnosed cancers overall, and the most frequently diagnosed cancer in men. The 2018 global estimate of new PC cases exceeded 1.2 million with more than 350,000 deaths worldwide.  Over the last decade, new treatments combined with better use of existing therapies in early-stage disease have transformed...

Clinical Research: Phase 1 - Phase 4

Resource Document: 8 New Elements of the IVDR

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this resource document, we highlight eight new elements of the IVDR.

Consulting

Your Guide to 8 New & Revised Concepts to the IVDR

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this infographic, we highlight eight new and revised concepts presented to the IVDR.

Clinical Research: Phase 1 - Phase 4

Premier Insight 278: A Decade-Long Partnership Culminates in FDA Approval

Background Psychiatric conditions are complex, chronic, often debilitating diseases, and there remains a persistent need for novel medications with proven efficacy and safety. Many of the established antipsychotic agents are highly effective but are associated with significant side effects that may negatively impact adherence and patients’ experiences with treatment. Thus, recent research has focused on...

Study Design

Premier Insight 279: Executing a Dual-Submission Study

Background Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires...

Study Design

Premier Insight 280: Engineering a PMA Study

Background Colorectal cancer (CRC) is the second most deadly form of cancer – although it is among the most curable and the easiest to detect in its early stages. The reason: patients notoriously avoid colonoscopy, placing themselves at unnecessary risk. Our client developed a unique solution – a multi-target, noninvasive screening test that could be...

Clinical Research: Phase 1 - Phase 4

Premier Insight 277: Optimizing Enrollment for a Phase 3 Clinical Trial During a Global Pandemic

Background A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV). We leveraged our expertise in study design and execution along with our extensive network of OB/GYNs to deliver a successful clinical study ahead of...

Study Start-Up

Premier Insight 275: Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial

Background The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex and the approval pathway depends on product classification. The EMA’s Committee for Advanced Therapies (CAT) is responsible for providing scientific recommendations on the classification of ATMPs as either gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), tissue-engineered products (TEPs),...

Premier Insight 274: Site Selection, Manufacturing, and Long-Term Follow-Up in a Transition Phase 1/2 Gene Therapy Trial

Background Designing and conducting a gene therapy trial is a complex undertaking. Understanding, planning for, and overcoming the myriad of challenges of operationalizing these studies will help you bring safe, breakthrough treatments to patients with unmet medical needs. Premier Research recently faced these challenges firsthand while operationalizing a transition Phase 1/2 trial involving localized administration...

Patient and Stakeholder Engagement

Premier Insight 273: Conclusive & Positive Results Delivered Ahead of Time – By Eight Months

Background Patients rushed to enroll almost as soon as word of the study got out. We were dealing with a significant unmet need: Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists. But there was no approved, effective pharmacologic treatment. And patients desperately wanted one. Objective With unanticipated interest...