The industry has stepped up with various cloud-based solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF)—all quantum leaps—yet lengthy cycle times, lasting nearly seven years,1 are still commonplace. A key reason is that they do not address the one part of a study’s lifecycle that strongly impacts the overall timeline of clinical trial conduct—study startup (SSU). As more stakeholders acknowledge that better SSU processes are essential for shorter clinical trial timelines, SSU has become the last major frontier in clinical trial automation, the final holdout where spreadsheet methodology still looms large, and where innovation is making a resounding difference.
The integration of the TransPerfect Life Sciences electronic Trial Master File (eTMF), Trial Interactive, with an Institutional Review Board (IRB) system offers the opportunity for automated oversight, resource optimization, compliance, and an improved patient experience. It also serves as a proof-of-concept to explore opportunities for more integrations.
eSource (or electronic source data) is up and coming in the healthcare and clinical trial industry. Electronic Data Capture (EDC), Electronic Health Records (EHR) and Electronic Submission (eCTD) are more well-known and have a wider understanding within the industry than eSource does.
For many years, sponsors in the US have been able to apply for Accelerated Approval from regulators based on a surrogate endpoint. This approach is intended to speed products to market that treat serious or life-threatening conditions and that offer a benefit over current treatments.
The complexity associated with manufacturing a ‘living drug’ should not be underestimated and it is important to consider that each product will have its own specific challenges and complexities.
Accurate forecasting of clinical supplies has become increasingly important in the past several years as planning the amount of study drug and other materials required to complete a trial has grown in complexity.
Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.
Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.
A study examining all new molecular entity (NME) applications first submitted to the FDA between 2000 and 2012 found that several potentially preventable deficiencies account for significant delays in the approval of new drugs.
The phenomenal growth and utilization of online social networks has created a range of new opportunities for recruiting patients into clinical trials. From Facebook to Snapchat and Bebo to hi5, social networks offer sponsors a channel through which they can proactively and cost-effectively place trial information directly in front of potential participants.
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