Clinical trial management- What are the issues involved?
22 August 2018
With the growing number of clinical trials and increasing complexity across the clinical lifecycle, life sciences organisations are under pressure to improve study quality and execution. So what are the current issues involved?
For many companies running clinical development programs, multiple technologies are often in play in order to deliver the outcomes. A survey by Pharma Phorum found that the average number of applications used to manage clinical studies was four, with more than one third of respondents (38%) saying they used at least five applications for each study! This comes with challenges for all users as logging in via separate URLs with unique user names and passwords can become a pain, effecting study efficiency. So, just imagine being involved in more than one study…
A predictable concern for an industry so heavily regulated, many respondents feel constrained by the complexity of the guidelines they follow. Additionally, the variations between different regulatory bodies, and the challenges that brings, comes up repeatedly. As trials are increasingly looking to emerging markets in new countries, there is also the need to understand whole new sets of requirements.
Communication among stakeholders in the clinical research industry is integral to the success and improvement of a clinical trial. We are heavily reliant on email however this sits away from the compliant ecosystem, likewise with instant messaging applications such as WhatsApp and although the industry continues to adopt new forms of technology to enhance communication between sites, sponsors, patients and more, many industry relationships are still hindered by miscommunication and data privacy risks.
Document sharing and review can be cumbersome when either via email or using another route (secure FTP) and this comes with the challenge of many email servers refusing to accept email attachments over a certain size. This has meant that many of those involved in a clinical trial have resorted to applications such as DropBox in order to share documents which begs the question, are any of these methods safe and validated?
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