Clinical Trials and Project Management
We are present in west and central Africa where we have established a network of physicians and scientists as well as public health specialists. We have several years of professional experience conducting and supervising GCP compliant clinical trials in this area.
​We can assist you in the:
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Development and/or translation of your protocol, informed consent and other clinical trials documents
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Conduct of project feasibility assessment
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Preparation of clinical trial budget
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Preparation and contract negotiation
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Identification and/or initial contact with investigators and research centers
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Study site selection
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Study start up activities
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Data management
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Samples collection and analysis
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Study monitoring
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Preparation of study reports
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Study close out activities
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Community engagement activities
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In addition we can provide the folowing regulatory support:
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Information about the regulatory and ethic requirements
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Preparation of the application dossier to ethic committees and regulatory authorities
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Translation of application dossier as needed
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Submission of the application dossier to the ethic committee and regulatory authority
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Interaction with ethic committees and regulatory authorities
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Advertisement and community engagement activities
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Preparation of interim and final reports
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Preparation for GCP inspections and Audits
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On site GCP training
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Organization of meeting with Ethic committe and regulatory authority
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Preparation of Standard Operating Procedure
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Site monitoring
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