MENA is a dynamic clinical research consulting company located in the United Kingdom with extensive connections to the European and Middle East health care and clinical professionals. The company's vision is to provide the highest quality customized and flexible service to pharmaceutical, CROs and biotechnology, clinical trial centers and ultimately, to the clients we serve. Whether the outsourcing need is short-term or long, MENA- CRC provides a significant range of clinical trial related services.
Amer Omar, the founder has 10 years of extensive experience in designing, execution and management of clinical trials in different parts of the world including Middle East, Eastern and Western Europe, USA and Canada.
MENA - CRC has an extensive experience interfacing with European, North American, and Middle Eastern central and local Ethics Committees, Institutional Review Boards (IRB) and the Ministries of Health and can provide Phase I, II, III and IV, site initiated trials, post marketing and Rx to OTC conversion studies support including submissions and feasibility studies.
Our commitment to you is :
- Assuring regulatory compliance
- Professional and qualified compliance auditing
- Senior-level, experienced consultants
- ICH-GCP guideline observation
- Professional, quality services
- Providing value to our clients
- Safety and welfare of subjects
- Timely completion of clinical trials
- Quality professional medical writing
* The following are some of the services we offer in the consultancy :
Project management:
- Global Project Management in Europe & Middle East (EMEA) & North America (USA & Canada)
- Clinical Development Plan Design.
- IMPD design and writing.
- Protocol & CRF's design and medical writing.
- Operation Manuals & Essential document package design and execution.
- Clinical Trial Services and consulting (Phase I- IV)
- Ethic committee, Regulatory and Ministries of Health submissions
- Pharmacovigilance (SUSAR,SAEs & AEs) reports and correspondence
- Widespread of network of professionals around Europe, USA & Middle East.
* Site Identification:
- Site Identification/
- Feasibility Studies.
* Site StartUp:
- Study Setup (Including investigator/
- Regulatory Authorities & National, regional and local Ethics submissions
- Collection & handling of essential documents (EDpacks)
- Negotiation and handling of CTA's and budgets with legal departments
- Handling of translations.
- Setting up sites with materials needed for trials
- Training site staff to trial specific and industry standards (ICH - GCP)
- Performing investigator meetings- contents, logistics & administrations
* Site Management / Clinical
- Initiation and briefing study team/investigators on conducting the trial
- Sites monitoring and management from the pre-study visit until the close-out visit.
- Ongoing medical review for all CRF's/ Monitoring for the trial, SDV regularly.
- Site preparations for sponsor/ authority audits
- Drug accountability conduct and shipping or destruction of empty packages
* Site Close- Out:
- Performing close down visit, ensuring trial supplies are a accounted for
- Archiving study documentation and correspondence
- Preparing final clinical study reports & occasionally manuscript for publication.
Niche Markets Opportunities:
With booming population growth, excellent infrastructure and streamlined regulatory processes, the Middle East provides numerous incentives for clinical trial research.
Recruitment
With a population of nearly 300 million people, the Middle East supplies rapid patient enrollment with high patient retention rates
Partnership & Institutes:
MENA CRC have strong regional partnerships with well qualified medical professional and International Medical Centers and Investigators with strong trial experience, the standards of medical training is very high and knowledge of the guidelines laid down by the International Conference of Harmonization (ICH) and Good Clinical Practice is extensive
Regulatory & Ethics
MENA CRC understands the strict regulatory standards and the importation processes in the Middle East and possesses deep clinical trial submission expertise. Our medical and regulatory experts have strong understanding of the medical and cultural issues in the region which is essential to clinical success in the region.
We are very excited with the new laucnh as we have started operating in the Middle East with few Biotechnology companies who are interested in lowering their operating costs and have access to high standards of medical care.
