Insights On Trial Design

  1. The EU Qualified Person And Clinical Supplies

    Sue Mann, Managing Director and QP Consultant of Sue Mann Consultancy answers your questions regarding the QP process.

  2. Placing The Patient First In Clinical Trials

    This article discusses ways to adopt patient-centered drug development, changing the corporate culture and trial design, understanding patient needs and incorporating them into trials, and leveraging technology to conduct remote patient-centric clinical trials.

  3. Just-In-Time Packaging And Shipping Supports Multiple, Complex Clinical Trials

    This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics to craft the best clinical supply management strategies for their multiple, complex clinical trials.

  4. What Your Clinical Study Design Reveals About Your Clinical Packaging Needs

    To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.

  5. Use Your Summer Slowdown To Plan Ahead

    It’s important to take advantage of a slow-down in activities to plan for the future. Use any downtime during summer to plan ahead for your patient enrollment push in September and into the following year.

  6. Avoiding Roadblocks To Patient Recruitment In Clinical Trials

    This is the first in a series of posts to help you navigate some of the roadblocks that may impede your ability to enroll patients during the summer months.  

  7. Accelerating Patient Recruitment To The Finish Line

    If your recruitment campaign includes advertising, digital and social media should be a part of it. Sponsors are increasingly turning to platforms like Facebook and Twitter as a way to target potential patients, especially because of the flexibility they offer. 

  8. Roadmap To Recruitment: Avoiding Summer Roadblocks

    Summer time! We look forward to it all year long. The days last longer, school is out, the weather is warm and inviting, and it’s time to take a break. But…wait. Before you do, consider how summer holidays can derail clinical trial timelines.

  9. Feasibility Of Shipping Clinical Trial Drugs Directly To Patients’ Homes

    Conducting clinical trials for rare, debilitating diseases can be particularly challenging, owing to the smaller patient population with limited mobility and greater caregiving requirements. Direct-to-patient shipping of clinical trial drugs, while not typical, might help to reach these patient populations who otherwise would struggle to participate in and comply with clinical trials. However, implementation of this strategy is challenging because of many reasons such as the logistical considerations and regulatory requirements regarding patient confidentiality and quality control. Recently, Bioclinica collaborated with a sponsor to successfully ship study drugs directly to patients.

  10. Is Your PM Advancing Your Study Or Checking Boxes?

    The Power of RTSM Problem Solvers on your Team - You spend an enormous amount of time assessing technology vendors through RFIs, pilots and capability presentations. Not only must the technology fit your needs, but you also make a judgement call based on the trust and value of the future relationship. Ultimately, the decision may weigh in favor of someone you can envision your team working well together.