The clinical trial landscape is changing, with contract research organizations (CROs) assuming more control over clinical trials on behalf of drug company sponsors. With so many firms vying for business in the space, having the right set of tools to manage today’s complex clinical trials has never been more important. The right clinical trial management solutions allow CROs to bring sponsors up to speed briskly and with greater transparency.
Imagine you’ve hired a contractor to renovate your kitchen and a curtain is hung on the threshold, completely hindering your ability to see the project. You’re told that the curtain will be opened once a month so you may note progress. For the rest of each month, you’re left wondering whether any work is being done, if the project has hit snags, and if you approve of the project’s direction. I can think of few individuals who would stand for this type of arrangement and yet, until quite recently, that’s the way many CRO-sponsor relationships have functioned. Often, CROs relied on study team resources to manually produce status reports from disconnected spreadsheets and systems, which inherently limits in-stream visibility. But with emerging technology solutions, CROs are now lifting the proverbial curtain to get near real-time insight to trial progress and reveling in new-found business advantages.
The transformation is almost entirely owed to technology-enabled visibility. Transparent CRO performance not only improves the communication between sponsors and CROs, but has a trickledown effect on trial outcomes as well. In the quest to meet clinical trial milestones, successful CROs are saving both time and money by putting technology to work for them and offsetting the burden of digging through an ever-growing volume of study data to produce status reports and metrics.
With transparent information flows, insights are shared on sponsor-accessible platforms in near real-time. This automated approach ensures data is free of human error ― a big concern for CROs ― and produces an end product that CROs can share with confidence. No longer do CROs need to worry about error-prone reports; instead they can focus on proactively executing the trial against expected timelines and milestones.
An automated, cloud-based approach is also a major selling point for future business. The right clinical trial management solution positions a CRO well ahead of its competitors by offering the kind of transparency sponsors are looking for, and which will soon be an industry best practice thanks to the recent ICH E6 (r2) guidelines amendment.
The next generation clinical trial management system must enable CROs and sponsors to truly collaborate so they can effectively mitigate risks and increase efficiencies. The future demands a connected, centralized solution that minimizes complexity and enables study teams to manage clinical trials with confidence. CROs who take advantage of this sooner vs. later will have a significant leg up on their competitors – and will lead the way in transforming the manner in which trials are managed.
Brion Regan is Product Manager, Trial Oversight at ERT