Strategic Partners
AddClin Research is flexible enough to offer the full range of services or only participate in the clinical execution. Providing a full service, AddClin Research has a number of co-operating organisations, which include
- Local safety laboratories
- Analytical Laboratories
- Experts/organisations for data management, biometrics and statistics.
The safety laboratory, which AddClin Research uses, is SANAS accredited with quality control and assurance systems in place. They are regularly mock audited internally (either local or international) and also audited by sponsors. Furthermore, they have ISO 17025 certification.
The analytical laboratory has had a FDA audit in 2000 for which they were found to be GLP compliant as following the FDA Guidance for industry:
Bio analytical Method Validation Guidelines, May 2001 and operates in compliance pertaining to bioavailability and bioequivalence studies;
A partner in data management and statistical analysis has been previously involved with FDA study and has submitting work to be authorized in Canada, South Africa and throughout the EU. They have a track record of at least 300 BE studies over the last 15 years. They are audited from time to time on behalf of US companies; all auditors have found them to be GCP compliant to the standards required by the FDA.
Studies AddClin Research have completed
Why, consider research in South Africa?
AddClin Research is committed to you!
- Providing added value to all its stakeholders
- Personal service by a core group of highly skilled professionals, competent in consultation, design, planning, implementation and study execution, recording, administration and managing of studies
- Strategy to co-operate with the South African MCC for regulatory approval
- Trials conducted according to international approved Good Clinical Practice Guidelines
- Flexibility and expandable capacity
- To deliver quality as shown by successful sponsor audits including the South African MCC
- Standard Operating Procedures in place
- Adhering to prescribed timelines of the sponsor
- Interdisciplinary networking and cooperation
Strategic Partners
AddClin Research is flexible enough to offer the full range of services or only participate in the clinical execution. Providing a full service, AddClin Research has a number of co-operating organisations, which include
- Local safety laboratories
- Analytical Laboratories
- Experts/organisations for data management, biometrics and statistics.
The safety laboratory, which AddClin Research uses, is SANAS accredited with quality control and assurance systems in place. They are regularly mock audited internally (either local or international) and also audited by sponsors. Furthermore, they have ISO 17025 certification.
The analytical laboratory has had a FDA audit in 2000 for which they were found to be GLP compliant as following the FDA Guidance for industry:
Bio analytical Method Validation Guidelines, May 2001 and operates in compliance pertaining to bioavailability and bioequivalence studies;
A partner in data management and statistical analysis has been previously involved with FDA study and has submitting work to be authorized in Canada, South Africa and throughout the EU. They have a track record of at least 300 BE studies over the last 15 years. They are audited from time to time on behalf of US companies; all auditors have found them to be GCP compliant to the standards required by the FDA.
Studies AddClin Research have completed
Why, consider research in South Africa?
AddClin Research is committed to you!
- Providing added value to all its stakeholders
- Personal service by a core group of highly skilled professionals, competent in consultation, design, planning, implementation and study execution, recording, administration and managing of studies
- Strategy to co-operate with the South African MCC for regulatory approval
- Trials conducted according to international approved Good Clinical Practice Guidelines
- Flexibility and expandable capacity
- To deliver quality as shown by successful sponsor audits including the South African MCC
- Standard Operating Procedures in place
- Adhering to prescribed timelines of the sponsor
- Interdisciplinary networking and cooperation