Actalent’s Team of Clinical Research Associates Rescue Trial for Life-Saving Tumor Therapy

Client Profile

A biopharmaceutical company that develops therapies and immunotherapies for treating cancer and immunological diseases.

Market Factors:

The pandemic closed clinical trials to on-site monitoring. The pharmaceutical industry was forced to adopt remote models — many organizations for the first time. Finding and keeping talent amidst the great resignation added to the challenge.

The Client Challenge

Our client developed a new therapy for treating advanced tumors in cancer patients. If FDA approved, this medicine has the potential to help people beyond the reach of standard therapies.

The client, however, encountered serious problems during the dose escalation and dose expansion phases of their two-part clinical study. They discovered the trial's monitoring, which was overseen by a full-service contract research organization (CRO), was in disarray. Specifically, the CRO wasn't keeping up with monitoring visits, which should have been scheduled every 4-6 weeks for part one of the trial and 6 to 8 weeks for part two. At best, visits were happening several months late. At worst, in some instances, they weren't happening at all. CRO communication with the study sites was insufficient and there was very little oversite. That combination — a lack of consistent monitoring and communication — was delaying the entire study. Worse yet, the backlog of regulatory, drug accountability, protocol deviations, source data verification, aging data, and vendor queries were growing by the day. Furthermore, the work the CRO was producing did not meet client expectations. Visit reports lacked detail, clinical research associates (CRAs) were misclassifying protocol deviations or not identifying them at all, and critical documents weren't being filed in the trial master file (TMF).

It was evident the CRO personnel weren't experienced in oncology studies. This was a recurrent issue, along with high turnover and low-quality work that did not meet client expectations.

Any further delay or failure risked the loss of a potentially life-saving treatment for patients who desperately needed it, in addition to the years, resources, and untold dollars invested by the client.

The Actalent Approach

The client, knowing Actalent is unrivaled as a functional service provider (FSP) in clinical research, engaged us to rescue the study.

We quickly designed a niche solution built around a team of five senior CRAs — comprised of one in-house CRA at Actalent and four regional CRAs on-site — all with extensive oncology experience, effective communication and strong site management skills, and the ability to provide guidance and training on protocol specific procedures. We were also proactive in our approach by selecting regional CRAs that could pivot from remote to onsite monitoring when and where allowed, depending on the pandemic restrictions governing each site's jurisdiction.

Next, we scheduled multiple 2-to-4-day site visits conducted by the regional monitors — accompanied by the in-house monitor as a co-monitor — that covered each of the 18 study locations every 4 to 6 weeks. Most monitoring was done remotely, except at a few locations where limited on-site monitoring was eventually permitted. This approach quickly reduced the huge backlog created by the prior CRO and allowed a significant amount of data to be reviewed in a short amount of time, and the sites to get back on track with data entry and queries. This also ensured the client was able to meet an important data snapshot milestone on time.

Data quality greatly improved, too. This was a direct result of our monitoring team establishing clear and consistent communication with site staff at every study location. That, in turn, boosted site morale; everyone was appreciative Actalent put structured messaging and monitoring protocols in place. TMF compliance training, conducted by Actalent at every site, strengthened staff confidence, too.

With all stakeholders aligned, our monitoring team was able to take a targeted approach to source data verification (SDV) moving forward. Critical documents were gathered on a strict schedule for TMF compliance. Protocol deviations were reduced. Regulatory files, drug accountability, and aging queries were systematically addressed and documented with careful urgency. The backlog dwindled until all overdue queries were resolved.

Also critical was establishing weekly meetings with the client. This ensured continued alignment and the exchange of valuable feedback in real-time.

The Results

The study was back on schedule within a matter of weeks.*

Monitoring productivity improved by 40% in the first two and half months. Source data verification percentage went from 22% to 78% within four months.

An audit by the client yielded no negative findings, only outstanding feedback.

In fact, by every measured deliverable — SDV percentage, data management metrics, TMF completion metrics, CRA retention, report completion, and study timeline adherence — Actalent is exceeding expectations. According to the client, we achieved in four months what would've taken the CRO 12 to 15 months and more than 6,000 more hours to achieve. That equates to $1.3M the client saved by using Actalent.

Better results and fewer problems equal more time. On that front, we're saving the client — between their clinical trial manager, data managers, and site managers — a combined 15 to 16 hours per week. Quantified on a billable scale, that's more than $120,000 worth of hours they're getting back every six months.

Our team was also able to help the client identify potentially recoverable costs from the original CRO for services paid for but not performed.

With two-thirds of the study remaining, though, our most impactful and lasting results go beyond the numbers. We've solidified the client's remote monitoring model for ongoing and future studies. They also have an effective TMF compliance training framework. Our flexibility and skill allowed us to adjust to the study as it evolved and changed, without disruption or delay. And issues, if any, are quickly resolved through transparent communication.

Perhaps most importantly, the quality and consistency of our monitoring team strengthened the relationships between each site and our client. Today, turnover among site personnel is down and performance has increased significantly. That kind of turnaround, with such lasting impacts, is invaluable. Yet, it doesn't happen unless Actalent finds, retains, and utilizes best-in-class talent that is committed to meeting our client&'s specific needs.

Our client, once concerned and uncertain about the future of this study, is now satisfied and reassured. They trust Actalent. We ­­built that trust through accountability, communication, providing a higher level of customer service, and delivering a customized approach to solving their problems.

_{*Of note, shortly after Actalent joined the study a trial milestone was fast approaching. Actalent's ability to immediately increase the frequency and consistency of monitoring visits, as well as greatly improve the productivity and quality of source data verification, allowed the client to present those milestone results at a major scientific conference.}