Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- The pharmaceutical industry’s objective for equitable development necessitates faster access to and market authorizations for drugs, biologics, medical devices, and combination products in countries around the globe.
- The need for patient-centricity is driving focus on patient safety through lay language communication and improving data transparency in medical writing.
- The integrity of information from source to final documents with appropriate statistical and medical inferences is also critical.
- Our data-driven scientific content writing services eliminate non-judgment-based activities and help medical writers focus on core scientific and clinical interpretations for global regulatory submissions.
In this article
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. With the evolution of technology, clinical trials are becoming more and more complex due to new categories of data elements such as novel study designs, digital biomarkers, companion diagnostics, use of genomic data, advanced therapy medicinal products (ATMP), Software as a Medical Device (SaMD).
These evolving technologies require constant upskilling of medical writers to adapt and work with cross-functional experts across various segments, which include drugs, biologics, medical devices, and combination products.
It also requires medical writers to drive intense scientific deliberations and dialogues with cross-cultural multi-disciplinary teams across geographies to drive meaningful discussions and build mutual consensus.
Additionally, medical writers 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.
Our specialized services cater to various medical writing needs of the pharmaceutical, biopharmaceutical, and biotechnology industries throughout the product lifecycle. 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 |
|
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 |
|
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 |
reports and labels |
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 |
publications |
Strategic publication plans, manuscripts, posters, abstracts, and speaker decks |
Conference and workshop abstracts, and slide decks |
|
Global value dossier, the Academy of Managed Care Pharmacy (AMCP dossier), and evidence-based medicine support |
Health technology assessment (HTA) |
|
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 |
|
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, 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) |
Table 1 – TCS’ end-to-end medical writing service portfolio
Our medical writers bring precision and rigor to scientific arguments while analyzing 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.
Traditional document authoring approach has inherent challenges such as duplication of content, lack of a single source of truth, no seamless flow of content from parent document to child document, inconsistency of scientific information across documents, and delay in finalizing documents.
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.
We leverage our deep technological capability to continually explore the usage of cutting-edge technologies such as AI-ML and GenAI and seamlessly integrate content with context and technology. This helps expedite document development and submissions to accelerate market authorization.
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.
The technology-enabled content reuse approach also helps to shift from a document-based to a content-based approach for authoring regulatory documents.
Our medical writing accelerators allow writers to focus on scientific aspects and minimize non-judgement-based activities. 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 utilization 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.
