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Clinical Trial Legacy

A Stable Clinical Trial Study Team with Trial Legacy Capability Makes All the Difference

The smaller, niche CRO that is well managed, with stable clinical trial study teams that provide trial legacy capability, and are populated with experts in oncology ensures the commitment of permanent qualified CRAs needed for the successful execution of your trial.

As an example of trial legacy capability, at Scimega the same project team follows a Sponsor’s program from Phase I to II, and subsequently heads any scale-up to Phase III that follows. Thereby providing not only the necessary therapeutic alignment of personnel, but also the accessible knowledge of what is and has gone on with a study program from its outset. During this clinical development progression many of our team members remain consistently assigned to the program to further leverage our knowledge and experience on the program to the benefit of the Sponsor.

How CRAs Impact Successful Trial Outcomes

Extraordinary CRAs have skills beyond what appears on their resumé. The effectiveness of their soft skill set leads to team coherence between the CRA and site personnel. Open communication and prior experience with study sites is essential to detect risks before they become an issue. According to a collaborative study conducted by CRO Analytics and ACRP, the majority of 300 Sites surveyed expressed that frequent and open communication between Sites, Sponsors and CROs is the most important factor in clinical trial quality.

Each study is uniquely designed, but CRAs are generally the ones tasked with ensuring that all contributors to the clinical trial production chain work effectively on time, within expected scope, on budget, within regulations, and safely for all patients involved. This reality makes the function of CRA the most important contact that a Site has with the Sponsor. It follows, that CRAs from stable clinical operations teams with trial legacy capability can truly make all the difference as an important success factor for smooth and optimal study conduct.

CRAs Are Your Eyes in the Field

It really comes down to trust. When you enter someone else’s territory, such as a clinical research site for example, and expect them to do things for you the way you want them done, and when you want them done; knowing how and what to ask is ever so much more effective when you have an existing, solid relationship with them.

Seen one, seen them all simply should never be applied. Every site has slight nuances in the way they operate, many sites have adopted changes during the past 2-3 years, and most still suffer from staffing shortages. An important building block to a good relationship is a willingness to understand and adapt to these particularities. For instance, site personnel appreciate it when a CRA learns how the site team is organized and thereby contacts the correct team member with a certain request or inquiry. Saving everyone time.

In addition, site personnel notice and appreciate when a CRA communicates with them according to the site’s schedule. If a phone call is needed to check in on potential patients, the afternoon or morning after a clinic day might be the best time. Perhaps a study coordinator sets aside an administrative day every week and therefore appreciates an email on that particular morning to remind them of the data entry and/or queries in need of their attention.

By making a conscious effort to adapt to site personnel preferences, a CRA is seen as an understanding team-player. As a result, site personnel are more likely to reciprocate by communicating their needs and any concerns that could become a study risk if not addressed in a timely, efficient manner.

Seek Out the Best Team to Connect with Sites & Meet All Your Milestones

Choosing the right team can make or break your study. This is especially true for smaller, lean teams. Ongoing training programs and outstanding team-work led by stable study teams results in project continuity and builds trust within the site network. When sites can trust your clinical operations team to make functions and process as efficient as possible for researchers at clinical sites to carry out study activity with ease there is a real opportunity to build an active feasibility database that is founded on the live and ever-changing hard data you need for your study.

Only when team members feel valued – and this includes site team members – will your study be best served.

For example, the ability and willingness of Canadian sites’ within Scimega’s dedicated network to nimbly adjust to new situations serves Scimega’s mid-size and smaller sponsors well, and was particularly advantageous during the dynamic and rapidly evolving period of Covid restrictions. As a case in point, Scimega’s CRAs were the first allowed back into many sites when site specific attendance restrictions were lifted, and the management team was involved in high-level site discussions on how to best implement remote access to site databases in order to ensure that all study data was clean and ready for key milestones. Due in large part to the way in which as a niche CRO Scimega acts like a true site-partner.

Solid site relationships and deep background local knowledge, in conjunction with constantly evolving tools and out of the box thinking leads to new and leaner processes to maintain clean subject data and documentation at the site level in a dynamic and rapidly changing clinical research environment. And getting that hard active feasibility data you need can really only be successfully undertaken when there has been an ongoing investment in developing solid site relations over the long term, and built on the foundation of stable clinical trial study teams that are able to provide trial legacy capability.

In every instance Scimega works with your team to devise innovative solutions to address your unique challenges, bringing together the right combination of specialized expertise for your cutting-edge oncology trial. If you’re interested in learning more about the Canadian opportunity, explore an expansion with us!

Contributed by: Julie Martin, CEO

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