The Medical Affairs Department
The Medical Affairs Department joins with the four other service areas to ensure clients receive an integrated service tailored to their needs.

Services offered by the Department
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.

Medical Writing
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

Medical Monitoring
We offer a full medical monitoring service,including round-the-clock availability ofregistered 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

Strategy Planning
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 toensure that safe and effective therapies can be made available to patients as soon as possible.

Pharmacovigilance

• 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

ENQUIRIES

For further information, please contact our team using the information provided below:
Tel: +27 (0)11 470 2800
Email: enquiries@acro.co.za