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
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
