Benjamin Franklin is often credited with this wise warning: If you fail to plan, you are planning to fail. When it comes to study startup (SSU), and site activation in particular, these words ring true, especially as the clinical trials sector embraces planning as key to boosting study quality. With the availability of workflow-based SSU tools, proactive planning is within reach for stakeholders who view this function as pivotal to improving quality, as measured by audit-readiness and the likelihood of passing regulatory audits.
There is intense pressure to speed clinical trials and restrain costs, and given the burden of this duality clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data - at a faster pace, while sponsors and contract research organizations (CROs) are looking for ways to incorporate business intelligence (BI) into the eClinical systems they are using to empower oversight—turning raw trial data into actionable information.
Adaptive clinical trial design in oncology research represents an intersection of two major industry trends. One of these is the current prevalence of cancer clinical trials. Last year, Clinical Leader cited a GBI Research report that declared oncology the largest therapeutic area in the pharmaceutical industry pipeline. And the promise of immunotherapy continues to galvanize investigations into new cancer treatments. The other trend is the increasing popularity of adaptive trial designs, which have helped the industry neutralize major inefficiencies in their research - not to mention all the discussion and debate they have sparked among industry bloggers and thought leaders.
It’s a time of great evolution for clinical research. Recent years have seen a major expansion in the size and scope of industry operations. It’s increasingly common for clinical trials to cross borders, oceans, and continents. Studies and datasets are bigger, and protocols are more complex. All of this makes for a more intricate research environment than previous generations of sponsors and CROs ever imagined. Navigating that intricacy without jeopardizing study timelines is one of the definitive industry challenges today.
The next phase of the Drug Supply Chain Security Act (DSCSA) is approaching, and it is approaching quickly. This is an especially crucial year as manufacturers face the November deadline that requires packages to be marked with a product identifier, serial number, lot number, and expiration. From there, the remaining deadlines for other stakeholders in the life sciences supply chain are staggered throughout the remaining six years of the regulation’s 10-year plan. By 2023, the goal is to have achieved item-level traceability from end to end that will allow detection and/or tracking of suspicious or dangerous products in the pharma supply chain.
A leading global contract research organization (CRO) was manually uploading site documents and associated metadata into their eTMF. Due to the complexity of (SSU) and variability of regulatory requirements for study countries and therapeutic areas, determining when all the documents needed for filing existed in the eTMF without multiple QC checks was a time consuming and burdensome activity. As the organization scaled with additional study volume, the efficiency and quality of the data going into the eTMF was causing audit risk and increasing FTE costs.
During various deals, the M&A team in the Raymond James Nashville offi ce relied on cumbersome manual processes for due diligence. For instance, to handle the question and answer process, the deal team used traditional met hods, conducting diligence via email and with Microsoft Excel® spreadsheets. Buy ers would create individual spreadsheets with different tabs for each category of questions, and submit them to Raymond James’s deal team. The deal team members then manually tracked the status and response of each question to en sure they sent the correct answers to the right bidder.
It’s NOT just about reducing monitoring visits. It’s about using a solid process and the right people & technology TO RUN A BETTER TRIAL.
A leading global contract research organization was contracted to conduct a two phase global oncology trial on behalf of a mid-sized Pharma company. The study was comprised of both phase I (dose finding and dose confirmation) and phase II (dose expansion) components. The original goal was to activate 20-25 sites for the phase I component and an additional 55 sites to be on boarded for phase II. By the time the protocol was received, sites had been selected and the First Site Initiation Visit (FSIV) was targeted to occur in less than five months. The core regulatory pack was due for finalization within 11 days of receipt of the protocol.
It’s not often that two clinical data managers who are years apart in their experience feel equally at ease during a clinical trial. But this is precisely what took place at Ancillarie, a support services company that has been serving pharmaceutical and biotechnology companies since 2012. In 2013, seeking an electronic data capture (EDC) system to catalyze their clinical research, they began a collaborative relationship with Medrio. Since then, they have conducted three clinical trials using Medrio’s software – all dermatology studies. Over the course of those studies, both veteran and early-career data managers at Ancillarie have found Medrio’s software to be convenient and user-friendly, and have achieved comparable efficiency in their research.