Regulatory and Clinical Writing
Regulatory and clinical writing plays crucial roles in the development and approval of drugs, medical devices, and biologics. Regulatory writers ensure compliance with legal and regulatory requirements, while clinical writers present clinical data in a way that supports the safety and efficacy claims of a product.
Designing Clinical Study Protocols
Designing a clinical study protocol involves outlining the objectives, methodology, and statistical analysis of a clinical trial. It specifies inclusion/exclusion criteria, treatment regimens, and endpoints to evaluate the drug’s efficacy and safety.
Clincal Study Reports
A Clinical Study Report (CSR) is a comprehensive document that summarizes the methodology, conduct, and results of a clinical trial. It includes detailed data on efficacy, safety, statistical analyses, and adverse events.
Common Technical Documents (CTD's)
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Non Clinical Overview
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Clinical Overview
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Non Clinical Summaries
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Clinical Summaries
Investigator Brochure
An Investigator's Brochure (IB) is a document that provides clinical investigators with essential information about a drug or device under investigation. It includes preclinical and clinical data, potential risks, and safety information.
Patient Information Leaflets (PILs) are documents provided with prescription medications to inform patients about the drug's proper use, potential side effects, and safety precautions. They include essential details such as dosage instructions, possible drug interactions, and storage guidelines
Informed Consent Documents (ICF &ICD
Informed Consent Documents (ICF and ICD) provide essential information about a clinical trial to potential participants. The ICF outlines the study’s purpose, procedures, risks, and benefits, ensuring participants understand what’s involved
Summary of product characteristics (SmPC)
Informed Consent Documents (ICF and ICD) provide essential information about a clinical trial to potential participants. The ICF outlines the study’s purpose, procedures, risks, and benefits, ensuring participants understand what’s involved