FAY offers wide-ranging protocol development and review assistance to support the planning and commencement of clinical investigation studies. Our services are inclusive of drafting and reviewing study objectives, rationale, methodology, study design, eligibility criteria, theraoy and intervention details, endpoints, safety assessments, study plans, visit schedules, statistical considerations, and other protocol-specific requirements. We also conduct quality and consistency reviews to ensure alignment between study objectives, endpoints, procedures, and overall study requirements.
We offer an extension over compilation, review of Investigator’s Brochures, safeguarding that relevant nonclinical and clinical information is presented in a transparent, organized, and scientifically sound manner.
We provide development and review support for Informed Consent Forms where the study information is clearly and appropriately mentioned to research participants. Our services include integration of study objectives, procedures, potential risks and benefits, confidentiality, compensation-related information where applicable, voluntary participation, withdrawal decisions, and other study-specific information, with appropriate review for consistency with the approved protocol and study requirements.
We provide CRF design, development, and review services to facilitate systematic gathering of clinical trial data. We also help in filling the paper CRF forms as per protocol requirements and study endpoints into appropriate data fields, organizing visit-wise assessments, designing forms for safety and efficacy data, and reviewing CRFs for consistency. We can also support CRF-to-eCRF/database mapping requirements.
We also design, develop and review source documents required for clinical study conduct and site-level documentation. These may include source worksheets, clinical assessment forms, visit-specific documentation, laboratory-related records, medical history documentation, treatment records, and other study-specific source templates. Our focus is on creating clear and practical documents that support consistent data capture and traceability to clinical source information.
We provide development, review, and standardization of study-specific logs and forms required for site operations. These includes screening and enrolment logs, delegation logs, training logs, drug accountability logs, temperature logs, equipment logs, sample tracking forms, visit logs, deviation forms, and other site or study-specific records. Documents can be customized according to study requirements and operational workflows.
We help in preparation, review, organization of essential clinical research documents required throughout the study lifecycle. This includes support for documents related to study initiation, regulatory and ethics submissions, investigator and site documentation, training, monitoring, study conduct and any correspondence.
We provide detailed document review and quality-checking services to identify inconsistencies, omissions, formatting issues, discrepancies, and errors before finalization or submission. Reviews can assess scientific and technical content, consistency with the protocol and other study documents, terminology, cross-references, numbering, dates, version information, tables, formatting, and overall document completeness. This helps improve document accuracy, consistency, and usability.
We offer professional document formatting and standardization services to generate uniform and well-structured documentation. This includes standardized headings, fonts, tables, numbering, page layouts, headers and footers, document identifiers, version control, revision history, cross-references, and other document-control elements. Existing documents can also be reformatted and standardized according to client-specific templates or established organizational requirements.
We provide documentation and other requisite like protocol presentation for DSMB and EC approvals
