SRF Clinical trials coordination Centre (SRF-CTCC)

Soar Research Foundation has a well-established Clinical Trials Coordination Centre. This centre operates as a Contract Research Organization (CRO) and offer Clinical trial coordination and implementation infrastructure (space and services like Data management and analysis, Pharmacy, Clinical trial monitoring, finance & human resource management etc), expertise, and capacity building services within low resourced settings. This is in line with Soar Research Foundation’s vision of promoting research excellence within low resource settings in Africa. The centre is a solution to the challenges of both local and international investigators who seek to successfully implement their projects with low resourced settings. ... It is strategically located in Mbarara City, with its researchers having a long history of running clinical trials within Mbarara Regional Referral Hospital and other surrounding health facilities in the region that can allow easy patient recruitment, and Mbarara University of Science and Technology that has a research ethics committee that can serve as the REC of Record for clinical studies. We are well experienced and acquainted with the research regulatory framework in our settings.

SRF HQ

The SRF-CTCC focuses on: 1) Initiation of new research, 2) Implementation of collaborative research, 3) Offers a platform for mentorship of young researchers in Clinical trials. We achieve this through our very experienced team and our collaboration with universities, hospitals, and other strategic partners both locally and internationally. SRF-CTCC brings together a team of well- trained and experienced researchers with vast knowledge in implementing high-impact and quality clinical research within low-income settings. Some of our experts are outsourced from well-established and reputable academic and research institutions. SRF-CTCC is a clinical research support centre for researchers from public, private, non-governmental entities, both nationally and internationally. We encourage you to utilize our ever-ready research teams, spaces, services, and infrastructure to implement your research with the highest possible quality. We ensure a flexible work policy that can allow shared resources especially regarding human resource, which in our view is a desirable innovation more so in settings with limited resources including human resource. This also enables researchers to have major reductions in research budgets while maintaining high quality research implementation within these contexts.

SRF’S CRO services
  • Research initiation and protocol development
  • Grant administration and management
  • Clinical trial coordination
  • Clinical research documents development
  • Standard operating procedures development
  • Data collection coordination
  • Management of regulatory and Ethical compliance processes
  • Data management coordination
  • Pharmacy services
  • Clinical monitoring and quality assurance
  • Laboratory coordination services
  • Safety recording and reporting
  • Recruitment coordination
  • Patient retention coordination
  • Community engagement coordination
  • Scientific writing and research dissemination coordination
  • Clinical trials mentorships (researchers’ rotations)

Sites Selection & Feasibility

Determining country feasibility, site and investigator selections are crucial steps for any clinical trials, as it impacts the study for its whole duration.

It is the foundation for your clinical trials, ensuring appropriate planning and preparation. At SRF, given the long experience of our team in conducting clinical trials in low resource settings, we appreciate the importance of these steps, and we are capable of:

  • selecting the best sites and investigators, based not only on the recruitment potential, but also on the staff experience, staff availability, equipment and availability of an enabling environment.
  • anticipating and solving local challenges. Based on our experience and knowledge of each study’s specificities, we can identify the local challenges linked to your protocol, and propose solutions to overcome them (risk assessment and mitigation planning)
  • establishing a recruitment plan that will optimize patient flow. Health care system organization varies across countries, and understanding it allows to put in place the best organization to recruit the patients.
  • establishing a patient retention plan to preserve as much as possible the statistical power of the study along the implementation path.
  • identifying potential regulatory challenges. We carefully review each study protocol in order to identify the potential regulatory country-specific challenges that may arise, and we prepare a response.
  • Establishing community engagement plans including community advisory boards (CAB) which is a requirement in a number of countries. Some of our experts have participated in the top national task force that develop these community engagement guidelines and therefore more knowledgeable.

At SRF, we believe anticipation and planning are the cornerstone on which future success can been built and assured.

Regulatory Submissions

Regulatory submission process could vary across African countries.

Through our regulatory office with a team that has worked in multinational projects, we are able to master all country local regulations, guiding you through all the local specificities. In order to optimize the timelines, our research regulatory officers are dedicated to preparing submission files and establishing privileged relationships with regulatory bodies in each country. As for the imports, we continue to establish a network of reliable vendors (local depots, agents, custom clearance, couriers that can deliver in any country you seek to implement the study in order to facilitate the import and distribution to sites. In Uganda, we are very well positioned and experienced in this aspect of importation of the Investigational product and how to handle Material transfer agreements. We have developed and we maintain on a continuous basis, local SOPs on regulatory submissions and import management. SRF’s internal organization is aimed toward optimizing timelines, in order to reduce your TIME TO TRIAL IMPLEMENTATION.

Project Management

SRF appoints on each project a project Manager/site Investigator:

  • Unique contact person for the project management
  • Coordinates the trial teams at site.
  • Leads the development of every required documentation for the study e.g., SOPs, registers, logs, etc. We already have generic SOPs and document templates that we have developed during our previous clinical trials.
  • Management of other vendors (Warehouse, local lab, courier, brokers)
  • Reporting
  • Project follow up
  • Budget control

Monitoring

We understand your need to maintain compliance with trial protocol, local research regulations, sponsor requirements and data integrity despite the existing human resource capacity in resource limited settings. Thanks to SRF’s experienced Clinical trial monitors with vast local and international experiences, that enable us to provide the following monitoring services:

  • Qualification visits
  • Site initiation visits
  • Interim monitoring visits
  • Close out visits
  • Site management

All Project managers have more than 10 years experience in clinical research within low resource setting. Everyone working on a clinical research projects must have been trained on Responsible conduct of research in human participants or Good clinical practice or Good clinical and laboratory practices (in the case of laboratory personnel). Signing confidentiality agreements is a norm at SRF for all personnel involved in clinical research.

Pharmacy

SRF avails space for an onsite pharmacy with good air-conditioning and ensured safety for the Investigational products and other medications. Our Clinical pharmacists are well experienced in managing clinical trial pharmacy and in all the regulatory processes required for importation of medicines.

Laboratory services

SRF outsources the laboratory facilities and utilized those that are well accredited. Our Microbiologists are experienced in implementing clinical trials and the laboratory procedures involved during this process. We have made a listing of laboratories that are accredited, and which undergo external quality control procedures in Uganda. We always ensure that we have a back-up laboratory for each test needed in the trial.

Data Management & Analysis

SRF offers appropriate, validated, and documented services in data management and biostatistics for both interventional and non-interventional clinical studies. Data manager and statistician are involved from the start of the project and customize database to project specificities and source data for achieving the study objectives.

Our experienced data management staff can provide:

  • Protocol review
  • CRF design
  • Data management plan development
  • Data management plan development
  • Data entry (single or double entry)
  • Data review / Query management
  • Medical review
  • Coding (MedDRA/ WHO)
  • Custom reports
  • SAE reconciliation
  • Export of entered and analyzed data (STATA, Excel formats,…)

Statisticians can provide:

  • Protocol review
  • Sample size / power calculations
  • Statistical Analysis Plan creation / review
  • STATA programming
  • Tables, figures and listings
  • Statistical analysis
  • Generate data clarification forms.
  • Archiving

Scientific/medical Writing

We understand the importance of good writing. Our goal is to produce concise, substantive, and polished clinical documents and manuscript. Our writers have the writing skills, relevant medical/scientific education, and experience to produce on time requested medical writing. All of our scientific writing deliverables undergo a rigorous copy-editing and QC review to ensure they look good, read well, accurately interpret the study results, and comply with regulatory guidelines.

Pharmacovigilance

We can support with local safety reporting. Our regulatory specialist have a perfect understanding of local requirement and will support sponsor pharmacovigilance team for clinical trials conducted in Uganda and other countries in Africa.

Staff Outsourcing

Clinical Staffing is one SRF’s services. Finding high profile candidates with adequate clinical trial experience in resource limited settings is an important challenge, and overcoming it has strengthened our position as the leader and expert Contract research organization. Our team has been working together for over a decade in clinical trials in other organizations. We are indeed one of the sole CRO able to provide you the right person, adapted to the level of your needs: project managers, Study Coordinators, CTAs, CRAs, Senior CRAs, Project Managers.

To meet increasing demands that may rise beyond our existing capacity, we are intentional towards developing a comprehensive data-base of potential candidates, carefully screening them through a process of interview and experience-based selection. This unique tool will allow us to propose you the best candidates for your projects, bringing you the flexibility and quality you need

All around Africa we can propose you:

  • One individual or a whole Project Team (managed by your project managers or by ours)
  • Flexible FTE (no minimum)
  • Flexible period of time (no minimum)
  • All experience levels
  • Working in your premises or in ours

Training & Quality Assurance

Training and quality assurance are part of SRF organization. Our training and Quality assurance teams mainly focus their attention on SRF to train the team and implement internal audit plan but they can also provide the following services:

Training:

  • GCP training
  • SOP Training

QA services:

  • Site audit
  • Master file audit
  • Central lab audit
  • Pharmacy audit
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