The question used to be a relatively simple one: how can a pharmaceutical company conduct efficient and effective trials? As the industry has changed over the past decade, pharmaceutical companies need the ability to access study information in real time so they can make better decisions regarding the viability of a compound as soon as possible in the study process. In no uncertain terms, time equals money in this industry.
The number of clinical trials conducted per year, their complexity, and the percentage of trials experiencing delays have all been increasing in recent years, accompanied by spiraling costs and lengthening trial times. This trend, along with a rise in overall drug development costs, has been occurring at a time when governments, payers, and patients are demanding that pharmaceutical manufacturers provide evidence of measurable value for any new treatment.
This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.
As life science companies progress through clinical development towards regulatory submission, if a quality management and process is not laid out from the beginning they face significant risks.
The unfailing ability to complete enrollment on time, every time, has been the greatest yet most elusive need among clinical trial managers. While the value of the external patient is becoming more apparent, finding optimum solutions for integrating them into a study’s enrollment strategy is not so obvious. In their struggle to find answers, clinical trial managers experiment with, and try to piece together, services and offerings from a wide and disparate range of sources. The results are as varied as the choices. Now, a new approach to patient enrollment is emerging – one that could change the world of clinical trials.
When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.
It’s no secret that the adoption of new technologies in support of clinical trials moves at a pace considerably slower than other industries. Disruptive technologies in other sectors can change business models almost overnight.
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.
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