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Included in ACRO’s full service offering is Pharmacovigilance services for registered products. ACRO has a dedicated team working across the African continent providing services including:
- Field, review / triage and follow up incoming AE Calls and action Intake of Individual Case Safety Reports (ICSRs) from various sources
- Initiate Translation of ICSR if required
- Support and implementation of product specific Risk Management Plans (RMP) and Risk Minimization measures (RMM)
- Provide local and global teams with required information, trackers and documentation.
- Respond to safety issues in conjunction with the clients medical teams.
- Facilitate local literature search.
- Report AE’s to the regulatory authority as per regulations and guidelines.
- Facilitate SAE reporting for clinical studies in South Africa and designated African countries
- Train client personnel on AE Procedures
Activities and country specific requirements can be structured according to client needs.
ACRO provides a range of regulatory services to help clients develop interventions and negotiate the path from conception and discovery, through to the clinic and the market.
Using either ACRO’s or the client’s Standard Operating Procedures (SOPs), the Regulatory Affairs Department assigns a dedicated team to each project and works according to a client-approved project plan. The structure of the team is flexible so it can be customised to accommodate each client’s preferences and meet each project’s requirements.
CLINICAL TRIAL MANAGEMENT & MONITORING
Our functional team is experienced in the administrative and regulatory aspects of clinical research and drug development with an extensive network of contacts throughout the pharmaceutical industry in South Africa, the African region and internationally.
We have established cordial and productive relationships with regulatory agencies and other overseeing authorities and maintained active links with researchers in industry, government institutions and the academic community.
Using either ACRO’s or the client’s Standard Operating Procedures (SOPs), the Clinical Trial Management & Monitoring Department assigns a dedicated team to each project and works according to a client-approved project plan. The structure of the team is flexible so it can be customised to accommodate each client’s preferences and meet each project’s requirements. The clinical trial management & monitoring team has multinational study experience across a broad range of clinical areas.
ACRO provides a range of clinical trial management & monitoring and auditing services to help clients develop interventions and negotiate the path through the clinic and to the market.
We work with our clients to ensure that projects are delivered on time and within budget utilising four core components:
ACRO provides a range of medical services to help clients develop interventions and negotiate the path from conception and discovery through the clinic and to the market.
Our functional team is experienced in all aspects of Data Management, including design and maintenance of research databases; data staff management; development of standard operating procedures; writing of Data Management Plans; the design and implementation of quality control and quality assurance processes; data validation, SAS programming, and producing descriptive statistical reports.
ACRO provides a range of data management services to help clients produce high quality and timely data.
ACRO data management staff have a wide range of experience in the multinational environment. Our services are provided in a professional manner and in accordance with international standards.
TRAINING AND CAPACITY BUILDING
The Training & Capacity Building Department joins with the four other service areas to ensure clients receive an integrated service tailored to their needs.
The functional team has extensive experience in the clinical trials environment, in clinical trial management, monitoring, and training for a number of multinational and local organisations. This uniquely and adequately qualifies the team to provide training that is relevant and easily implemented in the workplace.
The team has performed accompanied site visits with junior monitoring staff and conducted training in Botswana, Malawi, South Africa, Rwanda, Uganda, Lesotho, eSwatini and Zimbabwe.
The Department Head is accredited as facilitator and assessor of the South African Qualification Authority’s (SAQA) Education and Training Development Practice (ETDP), a Sector Education and Training Authority (SETA).
ACRO is committed to building clinical research capacity on the African continent and has developed a range of training courses and services to meet this need.