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Technical Writing
Our specialty lies in technical writing services focused on clinical, quality, and regulatory documentation. This includes a comprehensive range of documents crucial for the healthcare and pharmaceutical industries.
Development of Clinical Documents
We have a proven track record in developing a variety of study-specific clinical documents spanning diverse product types. These include:
Clinical Study Protocols: Detailed plans conceptualizing the objectives, design, methodology, and statistical considerations of clinical trials. The final protocol is adherent to regulatory guidelines consisting of complete and exhaustive information.
Trial Participant Documentation: Informational materials for trial participants, ensuring clarity and compliance with regulatory standards such as Patient Information Sheets, Informed Consent Forms, Participation Cards, and subject diaries. We identify suitable vendors for translation services wherever applicable to the clinical study.
Case Report Forms (CRFs): Structured, customized CRFs made to capture complete clinical trial data sets as per regulatory requirements. We are adept at developing both hard copy and electronic CRFs using validated systems.
Source Data Sheets: Documents specifying the origin and management of data collected during clinical trials created keeping the study-specific requirements in mind.
Subject Diary Cards: These are documents where the research subjects are required to enter data pertaining to the Investigational Product Administration details are associated adverse experiences while they are on the clinical study. These must be designed carefully keeping the subjects in mind and should be in lay person’s easy to comprehend and understand and we have that expertise.
Investigator’s Brochures: Creating Summaries of essential and comprehensive information about investigational products for clinical trial investigators.
Clinical Study Reports: Our team of technical writers and regulatory experts provide comprehensive report compilation services that detail results of the highest standards to get the subsequent approvals/ propel your journey from concept to clinic.
Pharmacy Manuals: Detailed Pharmacy Manual guiding the Investigators and other Clinical Researchers on the team to understand all the details of the Investigational Product including the how it is manufactured, labelled and packaged, the storage conditions and method of administration etc.
Preparation of Study Plans
The effective project management of the projects is key to project success. Our expertise extends in preparing detailed study plans essential for the seamless execution and management of clinical trials. This includes:
Project Oversight Plans: A detailed project oversight plan is developed in consultation with the clients to ensure that all the required aspects for seamless project execution are covered and implemented at the time of project oversight to ensure compliance to protocol, key guidelines and regulations.
Monitoring Manuals: Guidelines and plan for study and site monitoring of a particular clinical trial project to ensure adherence to protocol, data traceability and integrity, trial subject protection and regulatory standard are adhered to.
Safety Review, Management and Reporting Plans: These are plans put together in consultation with the clients to ensure the entire process flow involved in the safety review, management and reporting of adverse events during clinical trials is clearly explained. The roles and responsibilities of the stakeholders are clearly spelt out with reporting requirements with stipulated timelines.
Trial Master File (TMF) Plans: Essential documents are the documents that establish that the clinical study followed the good clinical practice standards. Plans outlining the organization and maintenance of essential documents and data from clinical trials are documented in this plan in close discussion with the sponsor.
Pre-Approval and Post-Approval Documents
Our offer comprehensive support for preparing documents required for both pre-approval and post-approval stages of product development. This includes:
Common Technical Documents (CTDs) and Investigational Medicinal Product Dossiers (IMPDs): Detailed submissions containing scientific and technical data required for regulatory approval.
Product Monographs: Detailed summaries of product characteristics, indications, dosage, and administration guidelines.
Target Product Profiles: Descriptions of the desired characteristics of a product.
Prescribing Information: Information for healthcare professionals on the safe and effective use of products.
Medical Device Technical File/Dossier/ CE Technical Files: Documentation demonstrating conformity with EU Medical Device Regulation (MDR) 2017/745.
Medical Device Files: Documentation for regulatory compliance of medical devices.
Site Master Files: Comprehensive documents detailing the management and organization of sites manufacturing drugs, devices and special therapeutics.