FHI Clinical SA Proprietary Limited
Global, mission-driven contract research organization providing end-to-end clinical trial services and scalable functional support. Focus areas include protocol design, site selection and development, clinical monitoring, data management and biostatistics, regulatory and quality management, pharmacovigilance, laboratory support and outbreak response, with particular operational experience in resource-limited settings and vaccine development.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Instant budget estimate tool (study cost estimator)
Online intake form that generates a high-level, ballpark cost estimate for study planning based on protocol characteristics and geographic enrollment assumptions.
Instant budget estimate tool (study cost estimator)
Online intake form that generates a high-level, ballpark cost estimate for study planning based on protocol characteristics and geographic enrollment assumptions.
Services
End-to-end management of clinical studies including design, regulatory strategy, site selection, monitoring, data management, biostatistics, medical writing and final deliverables.
Scalable outsourcing of specific trial functions such as monitoring, data management, project management, regulatory support and pharmacovigilance.
Feasibility evaluations and data-driven site identification, including epidemiological and biosurveillance inputs to prioritize sites meeting disease-burden and capacity criteria.
Set up and management of study databases, automated discrepancy checks, statistical analysis plans, sample size and power calculations, and final statistical reporting.
Technical assistance, training and audits for laboratory compliance with Good Clinical Laboratory Practice and regulatory expectations.
Regulatory strategy, ethics and authority submissions, eTMF/TMF management, SOP development and quality oversight.
End-to-end management of clinical studies including design, regulatory strategy, site selection, monitoring, data management, biostatistics, medical writing and final deliverables.
Scalable outsourcing of specific trial functions such as monitoring, data management, project management, regulatory support and pharmacovigilance.
Feasibility evaluations and data-driven site identification, including epidemiological and biosurveillance inputs to prioritize sites meeting disease-burden and capacity criteria.
Set up and management of study databases, automated discrepancy checks, statistical analysis plans, sample size and power calculations, and final statistical reporting.
Technical assistance, training and audits for laboratory compliance with Good Clinical Laboratory Practice and regulatory expectations.
Regulatory strategy, ethics and authority submissions, eTMF/TMF management, SOP development and quality oversight.
Expertise Areas
- Clinical trial management
- Vaccine development
- Infectious disease clinical research
- Oncology clinical research
Key Technologies
- Cloud-based CTMS
- Electronic Data Capture (EDC)
- EDC-CTMS integration
- CDISC data standards
News & Updates
Press release announcing rebrand from former legal name to Total Trials and confirming continuation of existing operations and services.
Blog article describing use of cloud-based CTMS and EDC integrations to monitor enrollment and sociodemographic characteristics and improve representativeness.
Blog post discussing strategies to improve equitable access and representativeness in clinical trials, including site selection, cultural competence and community engagement.
Site and investigator spotlight describing affiliation with research sites in Kenya and examples of vaccine and infectious disease research collaborations.
Named finalist for Top Global CRO for the past two years.
Press release announcing rebrand from former legal name to Total Trials and confirming continuation of existing operations and services.
Blog article describing use of cloud-based CTMS and EDC integrations to monitor enrollment and sociodemographic characteristics and improve representativeness.
Blog post discussing strategies to improve equitable access and representativeness in clinical trials, including site selection, cultural competence and community engagement.
Site and investigator spotlight describing affiliation with research sites in Kenya and examples of vaccine and infectious disease research collaborations.
Named finalist for Top Global CRO for the past two years.