Clinical Content Authoring - Techsol Life Sciences

Content Authoring Services

Clinical Content Authoring

Our expertise enables sponsors to deliver accurate, submission-ready documents that withstand regulatory scrutiny and accelerate clinical development timelines.

Overview

At Techsol Life Sciences, we specialize in developing high-quality, regulatory-compliant clinical content to support global submissions for pharmaceuticals, biologics, medical devices, and Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies. Our clinical writing team provides end-to-end authoring, compilation, and submission support for critical clinical documents, ensuring alignment with ICH E3, E6(R2), and M4E(R2) guidelines, as well as evolving FDA, EMA, PMDA, Health Canada, and CDSCO requirements. Our expertise enables sponsors to deliver accurate, submission-ready documents that withstand regulatory scrutiny and accelerate clinical development timelines.

Techsol Expertise in Clinical Regulatory Content Authoring

Techsol has extensive experience in authoring a full suite of clinical regulatory documents that demonstrate efficacy, safety, and risk–benefit to support global submissions:

IND/IMPD Submissions: Clinical sections (Module 2.5 & 2.7), clinical trial protocols, IBs, and clinical study reports to support first-in-human and early-phase studies.
NDA/BLA/MAA Submissions: Clinical summaries, Integrated Summaries of Safety (ISS) and Efficacy (ISE), clinical overview, and pivotal clinical study reports supporting product approval and labeling claims.
Gene Therapy and ATMP Submissions: Specialized authoring for clinical trial protocols, LTFU plans, and clinical summaries addressing long-term safety, immunogenicity, shedding, and efficacy in line with FDA 2023 guidance and EMA CAT requirements.

Clinical CTD Structure and Key Documents

Our clinical authoring aligns with ICH M4E (Module 2 and 5) and eCTD structure:

1. Clinical Overview (Module 2.5)

Integrated summary of clinical development, efficacy, and safety
Benefit-risk evaluation for regulatory decision-making

2. Clinical Summaries (Module 2.7)

2.7.1 Summary of Biopharmaceutics & Associated Analytical Methods
2.7.2 Summary of Clinical Pharmacology Studies (PK/PD)
2.7.3 Summary of Clinical Efficacy
2.7.4 Summary of Clinical Safety (including ISS/ISE integration)

3. Clinical Study Reports and Supporting Documents (Module 5)

ICH E3-compliant clinical study reports (Phase 1–3, BA/BE, special populations)
Integrated safety and efficacy reports for pivotal trials
Patient narratives and appendices for regulatory submissions

Templates and Authoring Standards

Techsol templates comply with:

ICH M4E and eCTD Module 5 for clinical documentation
US FDA eCTD v4.0, EMA Module 5, PMDA and Health Canada formats

Tech-enabled authoring with:

Standardized CSR and summary templates
Integrated tabular and graphical data for readability
Secure document management through RIMS or VeevaVault

Clinical Authoring Workflow at Techsol

1. Source Data Collection and Study Report Compilation

Collect final TLFs (Tables, Listings, Figures), clinical database extracts, and statistical outputs
Ensure traceability from raw data to summary tables and narratives

2. Drafting Clinical Summaries and Overviews

Prepare Modules 2.5 and 2.7 using Techsol’s validated templates
Integrate statistical results, visual data displays, and safety narratives for clarity

3. Internal QC and Peer Review

Line-by-line QC for data accuracy and alignment with CSR/statistical outputs
Cross-check with protocols and SAP to ensure consistency

4. SME and Regulatory Review

Clinical, biostatistics, and regulatory SME review for scientific and compliance accuracy
Alignment with FDA, EMA, and ICH expectations for clinical content

5. Finalization and eCTD Publishing

Seamless integration into Modules 2 and 5 for IND, NDA, BLA, or MAA submissions
Pre-submission validation to ensure eCTD compliance and regulatory readiness

Common Challenges and Techsol Solutions

Challenges	Techsol Solutions
Inconsistent terminology across clinical study documents	Standardized glossaries, document harmonization, and cross-referencing
Linking safety and efficacy data for ISS/ISE	Evidence-based integration with clear benefit-risk narrative
Formatting or traceability errors in eCTD	Automated eCTD validation and QC-driven publishing
Tight submission timelines for pivotal studies	Parallel authoring and QC workflows leveraging dedicated medical writers and statisticians

Techsol Clinical Writing Capabilities & Value Proposition

Highly qualified clinical medical writers: With advanced degrees (M.D., Ph.D., Pharm.D., M.Sc.) and expertise in clinical pharmacology, statistics, and regulatory writing
Strong regulatory acumen: Across ICH E3/E6, FDA, EMA, PMDA, and Health Canada requirements
Integrated project management: Ensuring milestone adherence, communication efficiency, and risk mitigation
Tech-enabled workflow: With validated templates, version control, and secure document management systems
End-to-end value: From gap analysis to final eCTD submission-ready deliverables, ensuring high-quality, regulator-ready clinical documentation that accelerates approvals