The Clinical Trial Management & Monitoring Department
The Clinical Trial Management & Monitoring Department joins with the four other service areas to ensure clients receive an integrated service tailored to their needs.
This 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.
They 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.
Services offered by the Department
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.
Project Execution
We work with our clients to ensure that projects are delivered on time and within budget utilising four core components:
Team Cooperation
- To prepare investigative sites and staff for the conduct of studies
- To promote local regulatory and GCP compliance, enhance recruitment rates, enforce protocol adherence, and ensure the collection of quality data throughout the study
- To achieve timely data query resolution and proper record archiving after the study closeout visit
Clear and Open Communication
- Members of the ACRO team work together with the study site staff to ensure that all client requirements are met and timelines complied with
- Free and regular communication between CRAs and investigators and other site staff allows early detection and correction of any deviations from the protocol and inefficiencies in study conduct
- ACRO provides regular visit reports on study progress to the client
Local Availability
- The use of regional CRAs improves monitoring efficiency and reduces costs to our clients
- Our team includes members who have monitoring experience throughout the African region including Botswana, The Gambia, Ghana, Kenya, Malawi, Rwanda, Uganda, Zambia, Tanzania and Zimbabwe
- We are acquainted with specific local and regional regulatory and logistic needs, as well as with local community sensitivities.
Flexible Resourcing Models
- ACRO provides both insourcing and outsourcing monitoring models according to the needs of the client
ENQUIRIES
For further information, please contact our team using the information provided below:
Tel: +27 (0)11 470 2800
Email: training@acro.co.za