Excellence in Medical Writing Services
Precision in Medical Writing for Regulatory Success
Navitas Life Sciences is a leading medical writing CRO, offering top-tier medical writing services that cater to a wide range of therapeutic areas. Our highly skilled medical writing team, comprised of professionals with diverse qualifications such as MBBS, MD, PhD, and M. Pharm, is adept at producing high-quality clinical and regulatory documents. We specialize in clinical study protocols, patient-centric documentation, investigator brochures, comprehensive study reports, and regulatory medical writing services. Our writers are well-versed in global regulatory guidelines, including ICH-GCP, FDA, and EMA, ensuring that all documents are compliant and meticulously crafted to meet the needs of our clients. We also provide safety writing, web synopses, and documents tailored for research, demonstrating our versatility and commitment to excellence across various medical fields.
Your Strategic Partner in Medical and Safety Writing
At Navitas Life Sciences, we take pride in our holistic approach to medical writing. Our services, as one of the sought after medical writing companies, extend beyond basic documentation, offering comprehensive support throughout the clinical trial phases, from Phase I to Phase IV. This includes crafting clinical study reports, regulatory submission documents, and safety narratives. Our experience in responding to health authorities' queries during approval and post-approval phases further underscores our expertise in regulatory medical writing. Powering possibilities in medical writing services for seamless, integrated support that transforms complex clinical data into clear, evidence-based narratives. This ensures not only regulatory compliance but also the effective communication of scientific and medical information.
Our Medical and Safety Writing Services Include
Clinical Study Protocol to Complete Common Technical Document (and Submissions)
- Clinical Study Outline/Synopsis
- Clinical Study Protocol and Amendments
- Patient Information Sheet, Informed Consent Form and Patient Brochure
- Investigator’s Brochure, Investigator review materials
- CRF Out Flow
- Inputs SAP/Monitoring Manual
- Development Safety Update Report (DSUR)/Annual Safety Report (ASR)
- Clinical Study Report (CSR)
- CSR synopsis for public disclosure
- Subject Diary/Diary Card
- Patient facing Document (e.g., questionnaires for data collection, advertisement etc.)
- Clinical Overview (CO) and Non-Clinical Overview (NCO)
- Safety Risk Management Plan (RMP) and additional Risk Minimization Measures (aRMM) related documents
Medical Writing Experience Across Phases:
Our commitment to excellence is evident across a spectrum of medical writing services spanning various clinical trial phases:
Exclusive Oncology Medical Writing Expertise
Navitas Life Sciences brings unparalleled expertise in delivering numerous protocols, clinical study reports, investigator’s brochures, and eCTD submissions tailored for oncology research.
Types of Medical Writing Services
Medical writing can be broadly classified into
Aspect | Clinical Writing | Regulatory Writing | Scientific Writing |
|---|---|---|---|
Purpose | CTs | Regulatory submissions | Communicating original research findings and scientific knowledge |
Primary Emphasis | Communication of CT details and results | Preparation for regulatory approval processes | StockholmContribution to the scientific knowledge base |
Examples | CSRs, Clinical Protocols, ICFs | CTD summaries, IND applications, MA Applications, NDAs | Research articles, Review papers, Conference abstracts, Scientific presentations |
Brochure
Comprehensive Medical Writing Service
CASE STUDY
Providing End-to-End IND Regulatory and Medical Writing Services
Case Study
Integrated Clinical Data Services, Clinical Data Management, Biostatistics and Medical Writing
Extensive Experience in Managing Efficient Oncology Clinical Trials
Gain the Navitas Life Sciences Edge
Global Presence
Diverse Experience
Proven Benefits
Tailored Solutions
350+ Clients
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Medical Writing Services CRO: The Navitas Life Sciences Advantage
5 Factors to select the Best Clinical Trials CRO for Success
