Going Above-and-Beyond – What Can Your Specialized Oncology CRO Do for You?

Clinical research is a growing and fascinating field marked by increasing complexity and competitive surroundings. CROs can help their Sponsors overcome common pitfalls to study success through strict adherence to best practices.

While a CRO’s optimal operations design is critical to its ability to go above-and-beyond for your study with innovative solutions devised specifically for the unique challenges of your oncology clinical trial.

What Your Specialized Oncology CRO Can Do for You – Real World Evidence

An example of how an unwavering strategic focus of a specialized oncology CRO to deliver on its commitment to the Sponsor’s program is highlighted in the case study featured here.

The Challenge – Real World Evidence

A pivotal, large phase 3 study requiring early patient catchment: Patients who had a planned surgery as part of their standard of care were identified quickly and entered the trial

just in time to receive the investigational product prior surgery.

Added to this challenge is the complexity of the involvement of several different departments at the Site level, who are not typical collaborators in the standard of care setting.

Given its stable, experienced teamwork and ability to identify, advise on, and implement enrollment strategies within the complex field of oncology clinical research the specialized oncology CRO engaged in Canada was instrumental in developing the solution to get this important global trial back on track.

Given its stable, experienced teamwork and ability to identify, advise on, and implement enrollment strategies within the complex field of oncology clinical research the specialized oncology CRO engaged in Canada was instrumental in developing the solution to get this important global trial back on track.

The Solution – Real World Evidence

The key solution here was to engage key sites with access to sizable patient populations, and which were performing the surgery.

Another key strategy was to identify how the study design could fit compatibly within the standard of care and bring benefit to patients.

During the qualification and start-up process extensive in-person communication all site departments involved took place. The resulting map of a patient journey from diagnostic to surgery provided clarity around the processes in place within the standard of care, different at each different site.

This ‘patient journey mapping strategy’ thereby facilitated the establishment of a customized communication flow for each Site to optimize the early identification of potential patients, and facilitate collaboration between the various players, and different departments involved.

Real World Evidence – Real Results

The results that came of this innovative solution was that the Sponsor’s enrolment target was significantly surpassed.

Selection of the right sites meant a very high level of activity and engagement was achieved across Canada. In addition, by sharing the ‘patient journey mapping strategy’ devised in Canada to solve the major challenge of this global trial helped when applied in other regions to improve enrollment from 0.25 to 0.5 patients/month/site.

Consequently, enrollment closed on time, database locked and occurred as planned with the following additional achievements specific to Canada.

• Surpassed enrollment targets at Canadian Sites (237%)
• 92% of open Canadian Sites enrolled patients
• Success in the region led to additional Canadian Sites requested by the Sponsor

Your Specialized Oncology CRO – Scimega Research Consistently Goes Above-and-Beyond

With 20 years unparalleled Canadian oncology experience Scimega Research has an optimal operations design critical to its ability to consistently go above-and-beyond for every one of your studies.

This CRO’s overall SDV of 84.5% across all enrolling sites, at all times in 2018. With a 93% on-time site report delivery rate dispatched to Sponsors, compares extremely favorably to the 60% average typical of the industry.

Scimega is a specialized oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies. We consistently deliver our services with a strategic focus on Sponsor program success with clinical trial start-up times 50% faster than the North American average, premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies.

What Our Sponsors Say About the Results Scimega Helps Them Achieve …“

Based on Scimega’s metrics, we’re very impressed with where Canada stands in comparison to other regions, including the U.S, when sites are under your management and support. Hopefully we can learn from your ways to help get all our Sites worldwide in good shape!”

What Our Sponsors Say About Scimega’s Oncology Experts in Operations…

“You really set an example and I appreciate the great quality of your work. Thanks!”

These comments, along with the metrics and phase 3 case study overview shared above clearly reflect the caliber of combined skill and specialized expertise Sponsors can trust from Scimega.

Contributed by: Julie Martin, Director, Clinical Operations