Author: Trial Support

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Global Post-Marketing Study (PMS) For Type 2 Diabetes Mellitus (T2DM)/Hypertension

A global post-marketing study (PMS) is required to assess the long-term safety and efficacy of treatments across therapeutic areas. Two of the most prevalent and interrelated chronic diseases worldwide include type 2 diabetes mellitus (T2DM) and hypertension. When combined, type 2 diabetes and hypertension significantly increase cardiovascular morbidity and death, requiring ongoing pharmaceutical treatment and […]

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Clinical Trials For Implantable Medical Devices: An Overview of Gastric Cancer

Clinical trials for implantable medical devices are transforming cancer care by making therapies more targeted, less toxic, and, eventually, more effective. From drug-eluting stents and intratumoral drug delivery devices to implantable pumps, biodegradable implants, ablation probes, and biosensors, these advancements are transforming cancer care. They are intended to administer therapies exactly where most needed, while […]

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Managing Time-Sensitive Shipments in Early-Phase Clinical Trials: The Role of IOR/EOR

The timely delivery  of medical devices and ancillary equipments  during  early-phase clinical  trials  is integral as delays can push back study schedules and extend trial duration. Protocol adjustments may also be necessary as a result of these delays, which would hinder approvals and involve more paperwork. Sponsors frequently turn to new equipment or expedited shipping […]

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Planning Clinical Trials In Japan? Here’s How To Ship Your Ancillaries & Non-IMPs

If you’re planning a clinical trial in Japan, one of the most important (and often overlooked) aspects is how to properly ship your ancillary supplies and non-IMPs. In particular, lab kits, diagnostic devices, and other materials may be required. Therefore, navigating import requirements is not always straightforward. With strict regulations and detailed customs procedures, a […]

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Early Site & Investigator Engagement In HR⁺/HER2⁻ Breast Cancer Trials: Foundations For Better Trial Design

Early site and investigator engagement are the foundations of effective clinical trial design, ensuring that protocols are both practical and patient-focused. This helps sponsors refine eligibility criteria, diagnostic pathways, and recruitment strategies for any planned trial. This is especially required in Hormone Receptor-Positive (HR⁺)/Human Epidermal Growth Factor Receptor 2-Negative (HER2⁻) metastatic breast cancer, where ever-evolving […]

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Partnering With Site Networks In Rare Disease Trials: Why Is It Important For Your Clinical Trials

Partnering with site networks offers a strategic solution to overcome the unique challenges of conducting clinical trials in rare diseases. Limited patient populations, complex recruitment pathways, and the geographic dispersion of expertise often hinder the progress of these trials. By leveraging established relationships, specialized knowledge, and streamlined processes, site networks can enhance trial efficiency, accelerate […]

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Modernizing Clinical Trials: The Role of eTMF, CTMS, and EDC Integration

The integration of Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) is transforming how clinical trials are planned, managed, and executed. By connecting these systems, organizations can eliminate data silos, reduce manual errors, and ensure real-time information flow across trial stakeholders. This integration enhances regulatory compliance, improves trial […]

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Mastering Clinical Operations In Asia-Pacific: Overcoming Challenges With Smart Solutions

Clinical operations in the Asia Pacific are rapidly evolving, driven by increasing regulatory harmonization, diverse patient populations across all therapeutic indications, and the adoption of innovative technologies such as decentralized clinical trial platforms, real-time data capture and analysis tools, and AI-powered site selection systems, making the region a strategic hub for current and upcoming global […]

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Why India Leads Global BA/BE Studies in 2025: Strategic Advantages for International Submissions

BA/BE studies 2025 are essential for global generic drug submissions. As the number of submissions continues to increase, countries are actively enhancing their capabilities to keep pace. India has positioned itself as a preferred destination, supported by its technical expertise, growing infrastructure, and regulatory alignment. BA/BE studies are cornerstones in developing and approving generic medicines, […]

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Beyond The Feasibility Questionnaire: Rethinking Feasibility Assessments In Asia-Pacific Trials

In clinical trials, traditional feasibility is often assessed through a feasibility questionnaire means figuring out if a planned study can run, whether it’s practically possible, ethically sound, and likely to work at the specific site or within the region where it’s proposed. Beyond the feasibility questionnaire, determining if a clinical trial will work is extremely […]

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