Medical & Scientific Writing
Medical & Scientific Writing
Our team specializes in clinical research, particularly within the pharmaceutical, biotechnology, and medical device industries. We recognize the unique demands of this field and adhere to a 3C formula when crafting content: cross-functional collaboration, compliance across various regions, and customized success stories tailored to your specific requirements.
We offer flexible and adaptable workflows, ensuring that all projects are executed with the highest standards of quality and efficiency. Our integrated approach incorporates biostatistics and programming, providing a comprehensive solution to all writing operations.
We leverage cutting-edge AI-ML tools and automation technologies to identify and address productivity bottlenecks, while enhancing speed, quality, and cost-effectiveness throughout the product life cycle. Our goal is to empower our clients to achieve their objectives and leave a lasting impact in the field of clinical research.
Compelling Content, Scientific Solutions
- A perfect blend of experts from pharmaceutical, biotech, and medical industry
- Powerful network of global SMEs with a vast medical and scientific expertise
- Cross-functional work capabilities
- Conversant with different geographies
- Compliance-assured, timely delivery
- AI augmented agile workflows
Regulatory Medical Writing
Our experienced regulatory writers spread across the globe serve as an effective link between sponsors and their regulatory affairs consultants. Our research-backed regulatory submission services ensure a smooth regulatory approval process for our clients’ investigational medicinal products. From early phase to post marketing, our team of expert writers will provide support throughout the clinical development process. With our vast experience in global post-marketing activities, we can help ensure safe and effective access to novel products for patients across the globe.
Our Regulatory Writing Services Include:
- Clinical Trial Protocol
- Clinical Study Report
- Common Technical Document
- Briefing Books/Manuscripts
- Plain Language Summaries
- Investigators’ Brochure
- Clinical Trial Disclosure
- Clinical Evaluation Report
- Country-specific labelling
- Informed Consent/Informed Assent
Safety Medical Writing
Our medical writers’ vigilant approach assists our clients in keeping track of minute safety alarms associated with their new drugs or devices. Our medical writers are trusted resources for various types of pharmaceutical risk management plans and other pharmacovigilance safety deliverables due to their in-depth understanding of the nitty-gritty risk management process and global team experience.
Our Key Safety Medical Writing Support Covers:
- Pharmacovigilance
- Aggregated Safety Reports
- Risk Management Plans
- Global RMP
- Medical Literature Monitoring
- Individual Case Safety Reports
- EU RMP
- Integrated Services with Epidemiology, Biostatistical Programming, & Medical Review
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Medical & Scientific Communications
Regardless of how clinically sound the data is, it is the art of storytelling that adds value to the product’s scientific significance. Our qualified team of publication support specialists and evidence analysts showcases unrivalled expertise in the development and dissemination of new scientific knowledge.
Our MedComm Services :
- Manuscripts, Conference Abstracts, and Scientific Posters
- Manuscript Revision
- Manuscript Peer Review
- Copyediting and Proofreading
- CME and Patient education Materials
- Author response to review feedback
- Expert group discussions, Panel Discussions, Peer-Review meetings
Our value-added services for medical affairs & medico-marketing professionals cover:
- Product leaflet (LBL)
- Reference tagging
- Reference pack development
- Clinical Content Validation (with or without VEEVA VAULT)
- Medical Information
- KOL/DOL Engagement
Serving satisfactorily global clients, Genpro regulatory writers is your one-stop solution for all your regulatory needs.
Related Information
WHITE PAPER
Statistical Analysis and Visualization of Microbiome Data in Clinical Trials
BLOG
Sample Size Determination & Power Calculation – A Comparison Between SAS and R Programming
PUBLICATION
Automating SDTM – Get It Prepared With Your Voice
