Flexible Service Provider Support

Because Total Trials clinical trial expertise is built in some of the world’s most challenging research environments, you can trust us to provide your FSP solutions in the markets you aren’t in. Our deep bench in areas like sub-Saharan Africa, Southeast Asia and the United States makes us uniquely qualified to provide clinical FSP support for monitoring and regulatory tasks in-country.

We strongly believe in being your Flexible Service Provider and our ability to hire in locations across the globe includes cost-competitive areas such as India, the Philippines, and sub-Saharan Africa allowing us to provide the right staff to augment your team and fulfill your needs.

We can support data management, biostatistics, medical monitoring, medical writing, post-marketing and many other technical needs with a team that blends the necessary expertise at the desired cost.

Flexible, Function-Specific Clinical Research Support

We embrace partnerships to provide the services needed by location or function and welcome structuring an MSA that allows you to call on our expertise rapidly to execute new task orders.

More than half of our contracts have been for FSP services in support of sponsors and other CROs.

Don’t wait to make the decision, when we can provide your regulatory, monitoring, and biometric needs in Africa, Southeast Asia, the US and globally now.

We welcome long-term commitments so our expert staff can provide rapid support and where greater volume means lower overall costs to you.

How can we best support you?

Case Study #1

For more than a decade, we provided regulatory, medical monitoring, and pharmacovigilance FSP services to a large CRO supporting DAIDS-funded research in South Africa. Our local and infectious disease expertise was crucial to this work, which started with the first HIV vaccine trial to be conducted in South Africa.

Key features:

We regularly supported more than 10 active protocols at any given time.
Staffing included 3 Regulatory Affairs personnel, 3 Medics and 2 Safety Officers. Many of these staff were part of the contract from inception to close per DAIDS requirements.

DAIDS’ satisfaction with the quality of our services, meeting timelines of deliverables and responsiveness to ad hoc needs resulted in more than 10 consecutive annual renewals of the subcontract.

Case Study #2

Since 2024, we have supported the NIAID-funded LaRed Network in Mexico to conduct collaborative clinical research addressing emerging threats, increase scientific knowledge, and directly contribute to improved clinical management of infectious diseases of public health importance. We were awarded this work in part due to our proven success supporting similar networks in ex-US settings. Our primary scope includes human resource management of the LaRed staff, along with training, QA/QC, and administrative, IT, and procurement support.

Key features:

During our engagement, LaRed has run 5 clinical trials and maintains a warm base of rapid-response-ready staff in the event a future pandemic requires immediate clinical research.
We currently provide HR management of 21 staff and have managed 49 total staff over the life of the project.

Based on the quality of our performance, NIAID has renewed our support at the end of each contracting period to date.

Case Study #3

Since 2023, we have supported a major US research hospital with FSP monitoring services in the United States and South Africa. These trials are focused on therapeutic products to combat bacterial infections. Our MSA with the hospital allows for rapid start-up of new trials and gives our customer the independent monitoring support needed to verify their trials’ compliance and further their research goals across multiple continents.

Key features:

Training hospital staff on the protocol, GCP, and specimen-handling procedures.
Verify CRF completion.

Based on our ability to effectively and efficiently provide on-the-ground support in the US and Africa, our customer continues to activate new protocols under this MSA.

Case Study #4

We provide end-to-end post-marketing Individual Case Safety Report (ICSR) processing to a major pharmaceutical company, from initial triage to archive. Our dedicated team manages ~40,000 cases annually using a focused approach towards adverse event case management, evaluation assessments, reporting and submission.

Key features:

100% compliance adherence
> 99.9% timely submissions

Due to our process standardisation and improved handling times, the client has experienced significant improvement in volume, quality and turnaround time.

From our roots in global development, we’ve learned to differentiate ourselves by embracing a responsive, agile, and adaptable approach to clinical trial implementation. This adaptability enables us to excel, and this is our approach to being your FSP provider. We provide our sponsors with the services and skills that are needed in a tailored way to ensure clinical trial success and efficiency from early phase development to post-marketing needs.

Flexible Service Provider Support