In late 2018, a leading therapeutic company was preparing for a large clinical study involving more than 1,500 participants across 20 sites throughout North America.
The clinical research investigations would serve a vital role in the global commercial release of a new product.
To address the needs of the large study, the client required additional project management, project coordination and resource support for the clinical trial.
The size of the study and geographically-dispersed investigator sites created challenges to the patient recruitment and enrollment, as well as clinical monitoring bandwidth issues.
In addition, the client was challenged to find resources with significant clinical experience within their therapeutic area of cardiovascular diseases.
Resources would need to cover five different geographic regions, manage the project timelines, ensure GCP compliance, negotiate contracts and collaborate with the client’s clinical research team.
HOW WE HELPED
Black Diamond pre-identified multiple candidates for the entire project team by searching our 5,000+ consultant network. Working collaboratively with client stakeholders, we helped them interview and select the Project Team within one week of being awarded the project. By the second week, the Black Diamond Project Team was on site and holding a kick-off meeting at the client’s offices.
Along with the client’s SMEs, we created a Project Charter to define project Scope, Schedule, Resource Plan, Budget, Assumptions, and Risks, gain client stakeholder approval, and ultimately execute per plan and deliver effective management, clinical monitoring, data collection, and GCP compliance for the critical clinical study.
Using our custom staffing model, we delivered an as-needed project team for this two-year project, ensuring that only required resources were allocated on a month-by-month basis. The project was a success and resulted in a working relationship that continues to this day.
WORKING WITH BLACK DIAMOND
At Black Diamond Networks, we have incredible depth of talent and expertise to help CROs meet aggressive timelines and with the nuanced technical expertise required for a variety of therapeutic compounds.
- Provide CROs flexible options to expand their service offerings and the ability to take on more projects
- Cover project gaps and build CROs’ depth of technical expertise with rare, hard-to-find experts
- Directly support complex and global studies with clinical expertise in specialized therapeutic areas
- Provide experienced Clinical and Regulatory experts as-needed, with immediate turnaround
Roles we filled for World-class CROs
- Clinical Data Managers
- Medical Monitors
- Clinical Research Associates
- Medical Writers
- CMC experts
- eTMF specialists
- Regulatory experts
Need project support?
We’re supporting clients on a variety of scales – by overseeing and staffing multi-site projects to sourcing individual subject matter experts. How can we help you? Let’s discuss.