INSIGHTS ON CLINICAL TRIAL DESIGN

  • Using Remote Clinical Research Site Monitoring During COVID-19

    Here are some of the challenges that research sites and monitors are facing right now – and how they can overcome them with remote monitoring.

  • A New Era In Dermatology: Study Design, Regulatory Strategies, And Patient Participation

    This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical elements when devising effective recruitment and retention strategies.

  • Platform Trials, Medical Supply And Cooperation For COVID-19 Vaccines

    COVID-19 has brought a number of stakeholders together to seek ingenious new methods for vaccines development. Here James Orbinski, who received the Nobel Prize as the head of Medecins Sans Frontieres joins Trevor Mundel, President of the Bill and Melinda Gates Foundation, Robin Mogg of the Bill & Melinda Gates Research Institute, and Derek Angus of REMAP-CAP, one of the largest platform trials in the search for a coronavirus vaccines, to discuss new opportunities for public-private and non-profit cooperation for vaccine development.

  • Ensuring An Unbiased Comparator Arm In Clinical Development

    Regulators in the U.S. and Europe have issued a positive response to the use of synthetic control arms (SCAs) in clinical development. The desire for faster and less expensive clinical trials, coupled with the availability of real-world data, were prominent factors. Learn how to avoid sampling bias when using real-world data in conjunction with SCAs.

  • Six Dosing And Safety Considerations In The Era Of Emerging Therapies

    Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies.

  • Mitigating Covid-19 Through A Hybrid Decentralized Clinical Trials Approach

    The covid-19 pandemic has presented the industry with many risks and challenges to the management of clinical trials. In this webinar, we will discuss what risks and challenges COVID-19 has presented, ways in which these can be addressed.

  • The Most Important Voice Is Missing: The Case For Including Patient Insights In Protocol Design

    Patient voice isn’t an accessory; it’s foundational. Patients are key to clinical trials, and relegating them to mere “subjects” diminishes their value. Including the patient voice in study design and development can make an enormous difference in recruitment, enrollment, and retention. Doing so also pleases regulators, who are increasingly putting a premium on patient-focused drug development. It doesn’t have to be difficult, but getting it wrong--or not doing it at all--can undermine a trial.

  • CAR-T Cell Therapies: Safety Considerations and Toxicity Management

    Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.

  • A Stepwise Approach To Data-driven Study Start-up

    COVID-19 has highlighted the urgent need for greater efficiency and streamlined approaches in clinical drug development. Study start-up has emerged as a key focus that could benefit from automation, as start-up activities account for 61% of total clinical trial cycle times.

CLINICAL TRIAL DESIGN SOLUTIONS

  • TrialScope Disclosure Management Brochure

    TrialScope Clinical Trial Registry Manager (CTRM) delivers the proven solutions clinical trial sponsors need to centralize, track, register, and comply with clinical trial disclosure processes, mitigating compliance risks while giving them greater control over their own clinical trial disclosure reputation.

  • Almac ONE: One Unified Clinical Trial Supply Solution

    Almac’s One Unified Clinical Trial Supply Solution has one objective to guarantee the study drug is with the patient at the right time while ensuring the complete chain of custody and minimising wastage of drug from production to destruction.

  • Optimize Clinical Trial Protocol Development

    Developing a clinical trial protocol is a critical step in this process. Poorly conceived protocols create challenges at the study level, the program level and across the full lifecycle of development and commercialization. BM® Study Advance helps you build quality protocols by providing the power of collaboration, AI and and real-world data to enable efficiency and informed decisions across protocol design and development.

  • Trial Management

    Oracle Health Sciences Trial Management and Monitoring Cloud Service is an integrated, purpose-built trial planning and management solution for today’s complex trial environment.

  • Clinical Packaging (Secondary)

    Experts in packaging patient kits and labelling.