Specialized Medical Writing Services with a Focus on Quality, Transparency & Scientific Value
Medical Writing plays a pivotal role throughout the medical research and clinical development process by providing accurate information about the safety and efficacy of medicinal products in various predefined document formats with regulatory authorities. Pharmaceutical organizations must have a highly reliable Medical Writing team who can draft accurate and complete information about the drug or device as per the mandated regulatory guidelines without any compromise in the scientific content quality.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
Our Scientific & Medical Writing Services
At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience in contributing to clinical development programs for global pharma companies.
Following are the key focus areas where our medical writing team has the expertise to deliver high-quality services throughout the drug / device development lifecycle as per applicable regulatory guidelines:
- Clinical Study Concept & Protocol Synopsis
- Clinical Study Protocol Development
- Phase I to IV – Study Design
- Clamp Studies
- PK/PD Studies
- Adaptive Clinical Trial Design
- PMS & RWE Studies
- Study Essential Documents Preparation
- Informed Consent Form
- Case Report Form & Patient Diaries
- Patient Information Sheet
- Survey Questionnaires
- Investigator Brochure
- Study Reference Manuals
- Clinical Study Reports (CSRs)
- CSR Synopsis for public disclosure
- Clinical and Non-clinical sections of the CTD
- Clinical Overview Summaries for EU and US
- Patient Safety Narratives
- Non-Clinical Summaries Preparation
- Non-Clinical Overview Report
- Permitted Daily Exposure (PDE) Reports
- CTD Module IV Non-Clinical Report
Medical Affairs & Commercial
- Abstracts, Manuscripts & Posters
- Marketing & Brand Content Development
- Medical Information Content Authoring
- Standard Response Documents
- Prescribing Information & Package Inserts
- Therapeutic Content Presentations
- Conference Poster Presentations
- Journal and Conference Submissions
- Medical marketing Reviews and Reports
- Scientific Literature Review Reports
- Clinical Investigation Plan
- CER Writing (Clinical Evaluation Report)
- PER Writing (Performance Evaluation Report)
- PMCF Plan (Post Marketing Clinical Follow up)
- PMCF Study Summary Report
- Manuscript Writing and Publications Support
- Biocompatibility Reports Writing
- Toxicology Reports Writing
- CMC / Analyte Report Writing
Safety Report Writing
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-risk Evaluation Reports (PBRERs)
- US FDA Periodic Safety Line Listings
- Risk Management Plans (RMPs)
- Development Safety Update Reports (DSURs)
- Local Safety Summaries (LSSs)
- Safety Signal & Risk Analysis Reports
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.