Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Growing trial complexity and expanding data volumes are increasing the pressure on medical writing teams to produce accurate, consistent, and submission-ready content within shorter timelines.
- The need for patient-centricity is driving focus on patient safety through lay language communication and improving data transparency in medical writing.
- AI-assisted, human-governed authoring helps medical writers accelerate drafting and review while strengthening consistency and traceability across documents.
- In our AI-led data-driven scientific content writing services, human judgment remains crucial to ensure the responsible use of AI-generated content, accurate scientific interpretation, and appropriate content finalisation.
On this page
Overview
The demand for high-quality medical writing services is on the rise worldwide due to evolving regulations and a greater focus on patient safety.
Pharmaceutical, biopharmaceutical, and biotechnology companies need to prepare large volumes of documents during the clinical development process to obtain regulatory approval for marketing new medicinal products. This requires a deep understanding of various non-clinical and clinical data across different therapy areas, knowledge of regulations, and statistical principles including statistical and clinical interpretation. Clinical trials are becoming more complex with new data sources and approaches, including novel study designs, digital biomarkers, companion diagnostics, use of genomic data, advanced therapy medicinal products (ATMP), Software as a Medical Device (SaMD).
Medical writers must engage cross-functional, cross-cultural teams across geographies to align scientific perspectives and build consensus. They [AP2.1]need to balance between complex information, and appropriate writing styles to present scientific information clearly and accurately to varied audiences.
Our solution
TCS medical writing services cover over 20 therapeutic areas, regulatory and scientific documents, and publications.
TCS combines medical writing expertise with AI-assisted content development to support drafting and review across selected clinical and regulatory documents. Medical writers retain responsibility for scientific interpretation, source verification, and final content review. We offer end-to-end medical writing services, as depicted in Table 1.
Function or unit | Our services during Clinical development phases – | Our services post-product launch |
Clinical regulatory writing | AI assisted development of Investigators brochures, protocols, informed consent forms (ICFs), clinical study reports (CSRs), clinical overviews (CO) and summaries, briefing books, and health authority question (HAQ) responses | Electronic common technical documents (eCTD) modules and post-marketing study documents |
Trial disclosures | AI assisted development of protocol and trial results summaries for registry sites, plain language summaries redaction, and anonymization services | Masking personal identifiable information (PII) in text, image, audio, and video |
Safety reports and labels | AI assisted development of drug safety update reports (DSURs), periodic benefit-risk evaluation reports (PBRERs), periodic adverse drug experience reports (PADERs), product labels, company core data sheet (CCDS), a summary of product characteristics (SmPC), and the United States prescribing information (USPI) | Periodic safety update report (PSUR), and label lifecycle management |
Scientific publications | Strategic publication plans, manuscripts, posters, abstracts, and speaker decks | Conference and workshop abstracts, and slide decks |
Health economics and outcome research (HEOR) | Global value dossier, the Academy of Managed Care Pharmacy (AMCP dossier), and evidence-based medicine | Health technology assessment (HTA) |
Commercial and educational content | Medical inquiry management, drafting content for health care professional (HCP) and patient engagement content, sales and marketing, content services, consensus papers, and the advisory board | Medical and commercial support |
CMC writing | Chemistry, manufacturing, and controls (CMC) writing, that includes information related to drug substance, drug product, and overall quality summaries | Product quality lifecycle management |
Medical device writing services | Investigational device exemption, AI assisted development of investigators brochure, instructions for use, clinical evaluation plans and reports, clinical investigation plans and reports, a summary of safety and effectiveness data, and clinical performance study plans and reports | Post-market clinical follow-up (PMCF) plans and reports, periodic safety update reports (PSURs), and the post-market surveillance report (PMSR) |
Content Automation Services | AI-assisted extraction and structuring of scientific concepts from authorised source documents; Biomedical terminology, taxonomy, and ontology management to support retrieval and content reuse; Content standards and metadata management | Retrieval and maintenance of approved product knowledge to support lifecycle document updates |
Table 1 – TCS’ end-to-end medical writing service portfolio
Our medical writers bring precision and rigor to scientific arguments while analysing complex medical information across diverse racial and ethnic populations. Supported by subject matter experts (SME), language editors, biostatisticians, and data analysts, we ensure accuracy through an independent quality control process, eliminating the need for oversight by our customers.
We adhere to various regulatory guidelines such as the International Council for Harmonisation—Good Clinical Practice (ICH-GCP), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).
We provide medical writing services to top global biopharmaceutical and medical technology companies based in the US, Europe, and APAC regions. TCS’ two decades of medical writing experience spans the entire value chain of clinical trials (phase 1 through phase 4). We author documents for regulatory agencies, physicians, patients, and researchers, and provide business consulting services to automate scientific content creation.
Benefits
We assist our customers in expediting regulatory submissions to facilitate quicker access to new medicines for patients.
Built on a foundation of responsible AI, traceability, and regulatory compliance, TCS solutions integrate seamlessly with existing clinical and content ecosystems, ensuring transparency, audit readiness, and human oversight throughout the process. TCS helps pharmaceutical and biotech organisations reduce authoring effort, enhance content quality, accelerate study and submission timelines.
Key benefits include:
Enhanced scientific rigor: Developing clinical documents with scientific rigor eliminates the need for resubmission to regulators, thus enabling faster patient access to new medicines.
Reduced turnaround time: Integrating automation techniques has facilitated accelerated content development and eliminated task duplication, resulting in a 25% to 30% turnaround time reduction across all clinical documents.
Assured high-quality deliverables: To enable swift regulatory approvals, our medical writers deliver high-quality documents across all clinical trial phases for drugs, biologics, medical devices, and combination products.
End-user orientation: TCS’ medical writers bring therapeutic area and regulatory expertise to contextualize their writing for diverse users such as physicians, researchers, patients, policymakers, and paramedical staff leading to better comprehension and experience for the end-user.
Quality assurance (QA): Our independent QA team regularly performs internal audits to ensure project quality and compliance. This ensures the audit and inspection readiness of project teams.
The TCS advantage
Our content scientists help organizations across the globe adopt data-driven intelligent content authoring.
Our AI, and GenAI capabilities integrate content, context, and technology to accelerate document development and support timely regulatory submissions.
TCS’ digital data flow approach enables the ‘create once, use often’ principle where information is created once as a content component and reused often across multiple documents. This allows medical writers to focus on analytical thinking and interpretation of clinical data, enhancing scientific rigor, quality, and consistency across documents.
We ensure intricate scientific concepts are presented concisely and cohesively by focusing on therapy area acumen, disease knowledge, regulatory guidelines awareness, statistical inferences review, and clinical significance understanding.
TCS’ medical writing experts have participated in key industry forums such as the International Society for Medical Publication Professionals (ISMPP), the Drug Information Association (DIA), and the Indian Society for Clinical Research (ISCR).
Cases in point
A Europe-based pharmaceutical company worked with TCS to develop 800 narratives for a pivotal phase 3 trial within a stringent one-month timeframe.
The narratives were focused on study outcomes and were not regular adverse event narratives, thus making it a more rigorous exercise. Our writers and consultants developed a comprehensive standard narrative template to capture various scenarios and mapped all the data sources in different sections of the template.
We deployed the TCS ADD™ platform to generate narratives. Our medical writers further refined the generated narratives to reflect scientific accuracy. This approach combined with platform and human intervention enabled the quick utilisation of different data sources, resolved data inconsistencies, and resulted in higher-quality narratives. We implemented a live narrative status dashboard, resulting in minimal customer supervision.
The company experienced a 70% effort reduction for narrative generation, 100% data accuracy, consistency in output, and faster processing of a large volume of narratives, enabling timely regulatory submission.
A global top Swiss-based pharmaceutical company digitized its scientific content creation process and facilitated data-driven content writing for digital data flow.
The company was dealing with a vast volume of historical documents across clinical trial phases that were readable by humans but not by machines. Some challenges included variations in scientific information, inconsistent document terminology, lack of content standards, and a need for more semantic interoperability of scientific information.
TCS’ SMEs thoroughly reviewed the customer’s landscape for scientific information. We developed a framework for intelligent content authoring, established vocabulary and standard definitions, created hierarchical relationships of concepts enriched with contextual information, and built a comprehensive clinical data model. We also constructed a content supply chain starting from inception (concept development) right through consumption (regulatory approvals). Additionally, TCS implemented an AI-ML, natural language processing (NLP), and natural language generation (NLG) solution for predictive content authoring.
The pharma major benefitted immensely with the unlocking of historical product knowledge, reduction of document finalization time by 40%, and enhanced accuracy in scientific documentation.