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Ophthalmology Trials: Managing Protocol Deviations in Visual Function Assessments

Image depicting managing protocol deviations in visual function assessments in opthalmology clinical trials

Protocol deviations for Visual Function Assessments (VFAs) in ophthalmology trials can affect the accuracy and reliability of outcomes. A VFA measures an individual’s functional or practical visual capabilities. This is in contrast to a standard eye exam, which includes a series of tests to measure real-world visual skills. VFAs perform both quantitative and qualitative assessments […]

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Accelerating Clinical Trials: The Market Advantage of Early Engagement

Illustration of a clinical trial process with early engagement of investigators and sites to accelerate drug development and gain market advantage.

In the drug development process, delaying the launch of a successful drug can result in lost sales. Early engagement to kickstart the clinical phase plays a key role in accelerating clinical trials and ultimately increasing revenue by providing earlier market access before competitors. Moreover, being the first to market a drug remains crucial for companies […]

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Early Engagement In Site Selection Strategies: Ensuring Investigator Commitment & Trial Start-Up Acceleration

Early Engagement in Site Selection Strategies

Early engagement in site selection relies on the involvement of high-performing investigators from the start. Every successful clinical trial requires an investigator who believes in the study and a site that feels committed to it. Even groundbreaking studies may stall without dedicated sites and investigators, forcing patients to wait and timelines to be exceeded. Early […]

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Blinded Monitoring In Thailand’s Clinical Trials: Specific Use Cases & Value For Sponsors

Blinded Monitoring in Thailand’s Clinical Trials

Blinded monitoring is the process of reviewing trial data without knowing who is receiving the actual therapy and who is receiving the control. This maintains the review process impartial, fair, and reliable. It reassures sponsors that trial findings are robust enough to meet international regulatory standards. In Thailand, where many clinical trials are large and […]

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Blinded Vs. Unblinded Clinical Study In Oncology: Overcoming Bias, Safety Challenges, & Regulatory Demands

Blinded and Unblinded Clinical Study in Oncology

One of the primary concerns when considering a clinical study in oncology is how to ensure that the findings are reliable, objective, and acceptable to the regulators. The solution usually involves blinding, and eventually, when necessary, unblinding. Blinding limits the possibility of bias by keeping patients and researchers unaware of the treatment they receive or […]

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

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

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 Implant 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

Managing Time-Sensitive Shipments in Early-Phase Clinical Trials

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

planning a clinical trial in Japan

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 & 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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