Our Services

Learn more about how we help our customers and community

Services Overview

PHARMACOVIGILANCE

Included in our full service offering is Pharmacovigilance services for registered products. We have a dedicated team working across the African continent. Activities and country specific requirements can be structured according to client needs.

REGULATORY AFFAIRS

We provide 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.

CLINICAL TRIAL MANAGEMENT

Our team is experienced in the administrative and regulatory aspects of clinical research and drug development.

MEDICAL AFFAIRS

We provide 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.

DATA MANAGEMENT

We provide a range of data management services to help clients produce high quality and timely data.

TRAINING AND CAPACITY BUILDING

We have extensive experience in the clinical trials environment, in clinical trial management, monitoring, and training for a number of multinational and local organisations.

PHARMACOVIGILANCE

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.

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REGULATORY AFFAIRS

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.

We work with our clients to ensure regulatory compliance and efficiency of:

  • Market entry for medicines, and complementary health product development plans
  • Clinical trial design and conduct
  • Marketing strategies
  • All regulatory related audit activities
  • Post-marketing maintenance and surveillance
  • Risk management plans for patients and products

ACRO ensures that regulatory norms are complied with in the development of medical devices, drugs, biologics, biotechnology products and complementary medicines.

  • Preparation of submissions at all stages of the development of medical devices, drugs, biologics, biotechnology products and complementary medicines.
  • Submissions on behalf of our clients to local and regional African regulatory authorities
  • Insourcing of regulatory pharmacists

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:

  • 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.
  • 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
  • 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.

ACRO provides both insourcing and outsourcing monitoring models according to the needs of the client.

MEDICAL AFFAIRS

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.

ACRO works with clients to generate required documents that have passed through a thorough and mandatory quality review process. Depending on the nature of the document, nonclinical, pharmacological, clinical, regulatory and statistical reviews are conducted, with review by the client included as an integral part of the process.

More specifically:

  • We work with our clients to evolve and produce documents required both locally and internationally during the nonclinical and clinical stages of drug development, for drug registration, and during the post-registration period
  • We assist with the development and writing of protocols, patient information and informed consent forms, investigator brochures, case report forms, and clinical study reports
  • We prepare and execute regulatory submissions, including clinical trial applications, periodic reports, and all submissions related to drug registration
  • We review promotional material to ensure scientific and medical accuracy and regulatory compliance

We offer a full medical monitoring service, including round-the-clock availability of registered medical personnel. Our services include:

  • Trial-specific training of investigators
  • Development of safety plans
  • Clarification and application of eligibility criteria
  • Interpretation of study requirements and procedures
  • Consultation on adverse events and serious adverse events
  • Writing of patient narratives
  • Expediting serious adverse event reporting
  • Ongoing assessment of study safety data

Working with our clients, we contribute to scientific, medical, and regulatory planning, facilitating identification of the most cost-efficient and time-efficient developmental pathways. We help to ensure that safe and effective therapies can be made available to patients as soon as possible.

  • Pharmacovigilance operations on behalf of the client
  • Assist with responsibilities of existing Pharmacovigilance operations.
  • Literature searches and social media monitoring
  • Training for client company representatives
  • Develop systems for Pharmacovigilance departments
  • Spontaneous reporting
  • Clinical reporting
  • Safety Follow-ups

DATA MANAGEMENT

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.

ACRO manages the client's clinical trial data according to internationally accepted standards on a 21CFR Part 11 compliant system. We will optimise resources to ensure that the management of the client's data from case report form development to database lock is carried out efficiently and affordably, either via paper-based CRFs or e-CRF solutions.

During the client's study, ACRO provides customised management reports, data listings and descriptive statistical reports that help the client track the flow of data and understand it fully.

Post-registration studies are used to answer important marketing or medical questions in less time, and at lower cost, than preregistration trials. They are also critical to collect data on real world experience with the product across all countries where the product is used.

ACRO provides a data management strategy which will cut back on time and expense without compromising the quality of the data. ACRO data management staff have extensive experience with post registration studies and have learnt to balance the flexibility and uniqueness of these studies without compromising the quality of the data.

ACRO carefully designs and plans audits to evaluate whether current data management practices adhere to the client's SOPs, regulatory requirements, and international standards.

Before embarking on the audit ACRO presents the audit plan for client approval, and after completing the audit, presents the findings and recommendations in a comprehensive report.

It can be difficult to make sense of large collections of data and to extract meaningful information. ACRO helps the client explore and understand their data by organising and describing it in illuminating ways.

ACRO provides training modules designed to empower data managers. These include:

    • Introduction to Data Management
    • Advanced Data Management
    • Understanding and complying with CFR21 Part 11

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.

ACRO's GCP training for investigative sites includes both theoretical and practical components. Delegates are exposed to theory, role play, group work, and individual learning exercises. This introductory 2 day course is aimed at site personnel at a beginner to intermediate level of clinical trial experience. Wherever possible, study specific materials are used to optimise learning relevant to the clinical trial about to be undertaken

ACRO also provides 1 day refresher GCP courses, this includes, classroom, virtual and online options

Each course is based on Local and International GCP and other local regulatory requirements as applicable; instruction on FDA regulations is added when required.

ACRO also provides introductory and refresher GCP training for Clinical Research Associates (CRA) and other members of the clinical team.

The GCP courses are accredited in South Africa and carry continued professional development (CPD) points.

The ACRO CRA training courses are accredited by the South African Medical Association.

The course consists of theoretical and practical components.

ACRO basic monitoring course for individuals who have at least six month experience in the research environment, and who have an industry recognised tertiary qualification. This course is divided into three stages of a two week classroom session, six month vocational training at the workplace, with at least one accompanied site visit by the ACRO trainer, and another five day classroom session to complete the course.

ACRO 5 day Clinical Research Associate (CRA) course aimed at individuals who have at least one year's trial experience, and who have an industry recognised tertiary qualification. The course concentrates on the roles and responsibilities of a CRA.

A 3 day course aimed at individuals who are currently employed in the clinical trial environment, ideally in a managerial position or who will be taking up such a position in the near future. The training includes both theoretical and practical components and its main focus is on project management within the clinical research environment.

ACRO's SCRA training includes both theoretical and practical components focusing on higher level skills required by SCRAs such as conducting feasibility studies and accompanied site visits, and soft skills. This 2 day course is aimed at individuals who have a minimum of three years experience as a CRA and who have performed monitoring visits at each stage of a clinical trial, and submitted applications to the local Regulatory Authorities.

This 2-day course is for individuals involved in providing administrative support in clinical trials. The course expands on how administrative activities contribute to the success or failure of a clinical trial, and provides delegates with a broader overview of the clinical trial process, and tips on how to maximise their efficiency and effectiveness.

ACRO provides training modules designed to empower data managers. These include:

  • Introduction to Data Management
  • Advanced Data Management
  • Understanding and complying with CFR21 Part 11

Working with the site and sponsor, ACRO's experienced team offers training and mentoring to potential and established clinical trial sites.

The training is modular and can therefore be adapted to meet the specific needs of a site to ensure trial preparedness.

ACRO can develop a start-up site or provide focused training to consolidate the knowledge of staff at an established site. Development assistance may include identifying facility and staffing needs, sourcing site infrastructure, assisting in the creation of site processes and SOPs, drafting job descriptions, and other activities.

Training blends theory and practice, and may include, amongst other areas and topics, the following: administrative training; monitor training and mentoring; the conduct of non-interventional protocols; the establishment of Community Advisory Boards; participant recruitment and retention; and GCP support.

Local input is sought to ensure that all training that is given is implementable, and all suggested solutions are feasible.

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