The center collaborates with universities, hospitals, and strategic partners, leveraging its experienced team for high-impact and quality clinical research. SRF-CTCC provides services in research initiation, protocol development, grant administration, clinical trial coordination, document development, regulatory compliance, data management, pharmacy services, clinical monitoring, laboratory coordination, safety reporting, recruitment coordination, patient retention, community engagement, and scientific writing.
SRF emphasizes careful site selection and feasibility, anticipating local challenges, establishing recruitment and patient retention plans, and addressing potential regulatory issues. The organization also manages regulatory submissions, optimizing timelines and navigating local regulations. Project management services include appointing a dedicated project manager/site investigator, coordinating trial teams, overseeing document development, managing vendors, reporting, project follow-up, and budget control. Monitoring services ensure compliance with trial protocols, local regulations, sponsor requirements, and data integrity. SRF offers pharmacy services, laboratory outsourcing, data management and analysis, scientific/medical writing, pharmacovigilance, and staff outsourcing for clinical trials. The organization prioritizes training and quality assurance, providing GCP and SOP training, as well as conducting site audits, master file audits, central lab audits, and pharmacy audits to ensure adherence to quality standards.
Sites Selection & Feasibility
- Thorough selection of sites and investigators based on various criteria for optimal study outcomes.
- Anticipation and resolution of local challenges with risk assessment and mitigation planning.
- Development of recruitment and patient retention plans to ensure study success.
- Identification and preparation for potential regulatory challenges in different countries.
- Establishment of community engagement plans, including advisory boards, in compliance with country-specific requirements.
Regulatory Submissions
- Mastery of local regulations across African countries, providing guidance on specificities.
- Dedicated regulatory officers for efficient preparation of submission files.
- Establishment of privileged relationships with regulatory bodies in each country.
- Network development for reliable vendors to facilitate import and distribution.
- Expertise in handling Material Transfer Agreements and maintaining local SOPs for regulatory submissions and import management.
- Internal organization focused on optimizing timelines for a reduced TIME TO TRIAL IMPLEMENTATION.
Project Management
At SRF, each project is assigned a dedicated Project Manager/Site Investigator, serving as the primary point of contact for seamless project management. Key responsibilities include:
- Coordinating trial teams at the site.
- Leading the development of essential study documentation, such as SOPs, registers, and logs, leveraging existing generic templates.
- Managing relationships with other vendors, including warehouses, local labs, couriers, and brokers.
- Ensuring comprehensive reporting, project follow-up, and effective budget control.
Monitoring
Recognizing the importance of compliance, SRF employs experienced Clinical Trial Monitors to maintain adherence to trial protocols, local research regulations, sponsor requirements, and data integrity. Our monitoring services encompass:
- Qualification visits.
- Site initiation visits.
- Interim monitoring visits.
- Close-out visits.
- Site management to guarantee the highest standards of research conduct.
All Project Managers at SRF boast over 10 years of experience in clinical research within low-resource settings. Personnel involved in clinical research undergo training in Responsible Conduct of Research in Human Participants, Good Clinical Practice, or Good Clinical and Laboratory Practices (for laboratory personnel). Confidentiality agreements are a standard practice for all individuals engaged in clinical research at SRF.
Pharmacy
SRF provides on-site pharmacy facilities with optimal air-conditioning, ensuring the safe storage of investigational products and other medications. Our clinical pharmacists are well-versed in managing clinical trial pharmacies and navigating the regulatory processes required for importing medicines.
Laboratory Services
SRF collaborates with accredited laboratory facilities, utilizing experienced microbiologists for implementing clinical trials and overseeing associated laboratory procedures. A listing of accredited laboratories undergoing external quality control procedures in Uganda is maintained. Ensuring redundancy, we always have a backup laboratory for each required test in the trial.
Data Management & Analysis
SRF offers validated and documented services in data management and biostatistics for both interventional and non-interventional clinical studies. Our data managers and statisticians are involved from project inception, customizing databases to project specifics and sourcing data to achieve study objectives.
Data Management Services
Data Management Staff
- Protocol review
- CRF design
- Development of data management plans
- Data entry (single or double entry)
- Data review and query management
- Medical review
- Coding (MedDRA/WHO)
- Custom report generation
- SAE reconciliation
- Export of entered and analyzed data (STATA, Excel formats)
Statistical Services
- Protocol review
- Sample size/power calculations
- Statistical Analysis Plan creation/review
- STATA programming
- Tables, figures, and listings creation
- Statistical analysis
- Generation of data clarification forms
- Archiving
Scientific/Medical Writing
Understanding the pivotal role of effective writing, SRF offers comprehensive scientific and medical writing services. Our dedicated writers possess the necessary skills, relevant medical/scientific education, and extensive experience to produce timely and high-quality medical writing. All scientific writing deliverables undergo rigorous copy-editing and QC review to ensure they are visually appealing, well-written, accurately interpret study results, and comply with regulatory guidelines.
Pharmacovigilance
SRF provides support for local safety reporting, leveraging the expertise of regulatory specialists with a deep understanding of local requirements. Our team collaborates with sponsor pharmacovigilance teams for clinical trials conducted in Uganda and other African countries.
Staff Outsourcing
Recognizing the challenge of finding high-profile candidates with adequate clinical trial experience in resource-limited settings, SRF offers Staff Outsourcing services. Our team, with over a decade of experience in clinical trials, collaborates seamlessly to provide the right personnel, including project managers, study coordinators, CTAs, CRAs, senior CRAs, and project managers. To meet increasing demands, we are intentional about developing a comprehensive database of potential candidates, ensuring flexibility and quality.
Services Offered
- Individual or project team outsourcing (managed by client or SRF)
- Flexible FTE with no minimum requirement
- Flexible period of engagement with no minimum commitment
- All experience levels catered to
- Work arrangements at client premises or SRF's facilities
Training & Quality Assurance
SRF prioritizes training and quality assurance to uphold the highest standards. Our dedicated teams focus on internal training and implementing audit plans. Additionally, they offer the following services:
Training
- GCP training
- SOP training
QA Services
- Site audit
- Master file audit
- Central lab audit
- Pharmacy audit
