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: Why You Really Need to Get This Right

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why we...

Clinical Researcher: Advanced Therapies – Strategies for Success in Clinical Development

Advanced therapy medicinal product (ATMP) development is on the rise. According to the American Society of Gene + Cell Therapy, there were 1,745 gene therapies in development in May 2021, 70% of which were in preclinical studies, and more than 1,300 of these candidates were in development for oncology, the most active therapeutic area. Given...

Addressing the Challenges and Opportunities in Gynecologic Cancer Research

WebinarDecember 1511 AM EST Despite the impact on women’s health worldwide, significant unmet needs exist in the diagnosis and treatment of gynecologic cancers. Located in the female reproductive system, many have a reputation for being “silent,” as they are often detected in later stages when treatment options are limited. However, the recent introduction of novel...

Using the 505(b)(2) Pathway to Streamline Regulatory Approval for Combination Products

In recent years, the number of approvals for combination products and 505(b)(2) applications has been rising. Combination products consist of at least two constituent parts, each subject to its own statutory and regulatory requirements. Unlike fixed-dose combination therapies, which consist of drug-drug combinations, combination products can include any of the following: A drug and a...

Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors

TORONTO (PRWEB) OCTOBER 27, 2021 — Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the clinical trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during initial planning, the focus is usually placed predominately on recruitment and not...

Phase 1 Trials: Strategies for Site Selection and Dose-Escalation

Introduction Designing and executing an effective Phase 1 trial for a novel investigational oncology product can be challenging. Every facet of the process, from site selection and recruitment rate analysis to trial design and start-up, is interconnected. A nuanced approach is important, and early, careful planning is critical. This white paper explores key considerations for...

Build A Better Oncology Patient Experience: Supporting Participants Throughout A Study

Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy...

Pharmaceutical Outsourcing: Optimizing Study Execution for Advanced Therapies

Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight...

Pharmaceutical Outsourcing: Reimagining the Patient Experience in an Evolving Clinical Trial Regulatory Landscape

“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring...