CRO (Contract Research Organization) companies can vary in size from global companies to small specialized groups.
CRO companies offer services across all clinical trial phases and therapeutic areas including Feasibility Assessments, Ethics Committee, Regulatory Submissions, Data Management, Statistical Analysis, Medical Monitoring, Safety Services, Central Lab Services, Medical Write Ups and Project and Vendor Management.
The key roles and functions in CRO companies include:
Clinical Operations Manager, Project Manager, Clinical Team Leader, Senior Clinical Research Associate, Clinical Research Associate, and Inhouse CRA (Clinical Research Assistant).
- Project management.
- Managing and coordinating all studies being carried out.
- Keeping track of all the project milestones.
- Support any potential investigations (supplying evidence of contracts, agreements, protocols and Case Report Forms (CRFs).
Head-Data Management, Lead Data Manager, Assistant Data Manager, Validation Programmer, QC (Quality Control)/QA (Quality Assurance) Coordinator and Data Entry Operator.
- Date entry and management.
- Data Quality Control (QC) and Quality Assurance (QA).
- Coordinating with the Operations team to resolve any issues.
- Clinical Data Management (CDM) software training.
Pharmacovigilance(Monitoring the effects of medical drugs after they have been licensed for public use).
Head Pharmacovigilance, Pharmacovigilance Physician, Safety Expert, Medical Monitor, QC (Quality Control) and QA (Quality Assurance) Coordinator and Data Analyst.
- Follow up and record all adverse reactions and pregnancy cases to Global Pharmacovigilance.
- Process cases in accordance with global and local Pharmacovigilance procedures.
- Answer any Adverse Drug Reaction (ADR) case questions from local Regulatory Authorities and Health Care Professionals.
- Assist the head of Pharmacovigilance with developing and maintaining the local pharmacovigilance (Standard Operating Procedures (SOPs) and work practice documents.
- To identify all local safety observational (Post-Authorization Safety Studies) in conjunction with Regulatory Affairs.
Head Regulatory Affairs, Manager, Assistant Manager and Executives.
- Ensures that regulatory documents comply with relevant guidelines for content and format and check content of docs are accurate and reflects information/data in the source documentation.
- Submission to Regulatory Authorities to parent countries and other markets.
- Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in correct format.
Business Development Manager and Executives.
- Promotion and business development (network, meetings, etc).
- Attend conferences and events.
Head – QA (Quality Assurance), Lead Auditor, QA (Quality Assurance) Executive and QA (Quality Assurance) Trainee/Assistant.
- Ensure staff has a complete and updated training record.
- Ensure Good Clinical Practice (GCP). Bring up any issues with sites or practices with the Director of Quality Assurance and Director of Medical Affairs.
- Maintaining control of Standard Operating Procedures (SOPs) to ensure all staff are following the right protocols.
Medical Writer and Executives.
- Clinical study protocol.
- Clinical research report writing.
- Documentation for regulatory submission.
- Writing up medical cases.
Medical Advisor and Executives.
- Develop scientific medical content for projects, ensuring that they meet international quality standards.
- Put together training manuals and product monographs.
- Provide input for new product development.
Novotech CRO is a global company which has offices in 11 locations across the Asia-Pacific. We have experienced leadership and on-site regulatory and monitoring presence in each country of operation to ensure that every project and trial is running smoothly.