LBR Success Stories
Rescue Study #1:
Flexibility & creativity to salvage lagging studies
Client Challenge:
A prostate cancer study managed by a large CRO was not meeting its goals. Because the client was relatively small, and therefore a lower priority to the client manager, the CRO did not put the required effort into the study. The sites felt no urgency and unsurprisingly ended up switching their attention to other projects.
LBR Solution:
LBR was able to quickly re-engage existing sites not contributing to screening and enrollment as well as add additional sites. The company provided a higher degree of personal attention to each site by increasing the number and frequency of monitoring visits. These changes resulted in reinvigorated enthusiasm with the sites’ staffs.
LBR further enhanced its special attention by instituting a regular monitoring schedule and maintaining the same monitors at its site throughout the study. Continued involvement with the site resulted in successfully meeting enrollment goals and yielding data that supported a label change within originally expected timelines.
Rescue Study #2:
Project management issues
Client Challenge:
The client of a medium-sized CRO reputedly was observing inconsistent monitoring due to a lack of management and oversight.
LBR Solution:
LBR was asked by the medium-sized CRO to rescue the study. The company brought the study under control by working with the sponsor to re-initiate the existing sites, adding sites, and changing databases. As a result, the study was re-initiated and completed on time. The resulting product was successfully submitted to the FDA and subsequently approved for marketing.
Rescue Study #3:
Solving operational logistics and creating a standard methodology
Client Challenge:
A large clinical development program involving evaluation of heavy menstrual bleeding required a new unique and difficult menstrual blood loss assay.
LBR Solution:
LBR developed an efficient and effective system from scratch. The company also developed and managed all logistics for shipping menstrual products to the various sites. This newly developed process was eventually taken in house and subsequently became a standard field methodology for running studies requiring menstrual blood measurements.
Rescue Study #4:
Developing operational logistics for drug shipments
Client Challenge:
Create a consistent and reliable process to ship highly labile drugs with a two-day viability.
LBR Solution:
LBR developed a process where frozen drugs could be shipped directly to patients every two days. This process included establishing a program for scheduling study drug shipments and managing shipment flows to ensure study drugs were available for proper study dosing.
Rescue Study #5:
Addressing fraud to save a project
Client Challenge:
Identifying fraud in clinical datasets.
LBR Solution:
LBR worked with regulatory authorities to address alleged study fraud and save a project. The company conducted a full investigation, collected all original data, met with the FDA and proposed a path forward for approval of the product. The FDA agreed with the approach. The data was evaluated and remediated, and the product was reviewed and approved for marketing without requiring additional studies.
Rescue Study #6:
Maintaining business continuity during the COVID-19 shutdown
Client Challenge:
Transition an ongoing study involving thirty North American sites to 100% remote by employing tele-monitoring and telehealth. During the shutdown the clinical sites restricted access for non-essential staff, including research coordinators and CRAs. However, the subjects needed to continue study medication and complete their safety labs. Study visits and study assessments could not be impacted.
Success:
LBR was able to successfully transition the study by quickly setting up a process for remote source data verification. Study labs were switched from central to local labs, telehealth visits were implemented for in-person site visits, and home health agencies were contacted to conduct home visits to take vital signs and complete other study procedures critical to patient safety and study data integrity.
The result included three data locks with 100% data cleaning and the submission of an NDA. The company demonstrated an ability to quickly adapt to changing conditions and deliver a high-quality data end product.
