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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →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 […]
Read More →