Protocols
We work closely with the medical, statistical, and regulatory team members (our own and the client’s) to design and prepare clinical protocols as per client objectives and ICH GCP requirements.
Clinical Study Reports (phase I - IV)
Our medical writing team prepares integrated clinical study reports using relevant information from the study protocol, statistical tables and listings, the investigator’s brochure, regulatory guidelines, pertinent literature, and selected patient case report forms.
Investigator’s Brochure and Updates
We ensure that the investigator’s brochure for a trial, and any update of that brochure, is presented in a concise, simple, objective, balanced and non-promotional form. This ensures that a clinician or potential investigator is able to understand and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial, and update the investigator's brochure as per client requirements.
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Informed Consent Documents
Our ICH GCP-compliant informed consent documents are presented in a simple and clear language suitable for patients.
SAE Case Narratives
Our medical writing team prepares narrative descriptions of both significant and serious adverse effects for inclusion in the final study reports.
Periodic Safety Update Reports
We review the worldwide safety data from published literature and ADR databases with the clients on marketed products to prepare Periodic Safety Update Reports (PSURs) in ICH/ EMEA-compliant format
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