Medical Writing Services CRO: The Navitas Life Sciences Advantage

What is Medical Writing?

Medical writing is the creation of meticulously structured scientific documents, spanning a range of materials including clinical research documents. Regulatory medical writing involves the structured crafting of documents intended for submission to regulatory agencies seeking approval for medical devices, drugs, and biologics. This includes clinical trial data, regulatory submission documents, post-approval reports, among others. It plays a crucial role in communicating research findings, clinical trial outcomes, regulatory documents, and patient-related information.

Medical writers craft documents that adhere to regulatory guidelines while maintaining scientific accuracy and clarity. The American Medical Writing Association (AMWA) certification plays a vital role in setting standards and providing resources for professionals in the field of medical writing.

Medical writing has seen a significant surge due to evolving regulatory standards mandating extensive documentation. Pharmaceutical companies are keen to optimize costs and accelerate drug development timelines, for which medical writing emerges as a pivotal support function.

Medical writing services serve as the backbone of communicating complex scientific information effectively, bridging the gap between clinical study and regulatory requirements.

Types of Medical Writing

The medical writing can be broadly categorized into three types:

Navitas Life Sciences: Leading Medical Writing CRO

Navitas Life Sciences stands at the forefront, offering comprehensive Medical Writing Services tailored to diverse therapeutic areas, ensuring clients meet their clinical and regulatory needs with finesse and efficiency.

Medical Writing Experts

Navitas Life Sciences has specialist Medical Writers with diverse qualifications including MBBS, MD, PhD, and M. Pharm. This rich blend of expertise ensures a nuanced approach to meet the unique demands of every project. NLS’s medical writing team has comprehensive understanding of various global regulatory guidelines such as ICH-GCP, FDA, and EMA .

Experience Spanning Clinical Trial Phases:

Our commitment to excellence is evident across a spectrum of medical writing services spanning various clinical trial phases:

Clinical Study Protocols: At Navitas Life Sciences, our proficient team of medical writers collaborates closely with clinical development teams to craft comprehensive clinical study protocols. Once the design framework is established, our adept medical writers transform it into a fully detailed document, ready for submission and compliant with ICH E6 guidelines. Embedded within the clinical development team, our writers ensure seamless integration and gather inputs from all pertinent study stakeholders. We maintain a flexible and agile approach, aiding teams in formulating protocols that incorporate the latest decisions in the intricate process of study design.

Patient-Centric Documentation: We prioritize patient welfare by crafting informative materials such as Patient Information Sheets, Informed Consent Forms, and Patient Brochures.

Investigator Support: Our team provides comprehensive support to investigators through meticulously crafted Investigator’s Brochures and review materials.

Comprehensive Study Reports: At Navitas Life Sciences, our skilled medical writers possess extensive expertise in composing clinical study reports across diverse therapeutic domains. We specialize in crafting reports that adhere to ICH E3 guidelines for studies spanning Phase I (encompassing clinical pharmacology studies), Phase II and III (focused on clinical efficacy and safety), and Phase IV (including safety registry and post-marketing observational studies). Working collaboratively with clinical, regulatory, and statistical experts, we ensure the development of precise and lucid reports and summaries.

Regulatory Medical Writing: Regulatory medical writing includes non-clinical & clinical sections (Module 2.4 to 2.7 of eCTD), and product labels (SmPC/PIL/PIs). NLS medical writing team is highly qualified and technically experienced in extracting relevant information/data from all sources, drafting, compiling, and reviewing documents.

Our team has experience in preparation, review, and finalization of the modules for USFDA, EMA and other country specific submission:

• Non-Clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Non-Clinical Summary (Module 2.6), and Clinical Summary (Module 2.7).
• Responding to the health authorities’ queries during the approval and post-approval phases of the product.

Web Synopsis: Leveraging modern platforms, we ensure concise and engaging web synopses for wider dissemination of research findings.

Safety and Evaluation: From safety narratives to integrated summaries of safety and efficacy, we ensure a thorough evaluation of clinical data.

Exclusive Oncology Medical Writing Experience

With a proven track record in oncology, Navitas Life Sciences brings unparalleled expertise to meet unique client needs. Our experience includes delivering numerous protocols, clinical study reports, investigator’s brochures, and eCTD submissions tailored for oncology research.

At Navitas Life Sciences, we blend scientific rigor, exceptional writing skills, and extensive experience to deliver unmatched medical writing solutions. Our dedication to excellence ensures that clients navigate the complexities of pharmaceutical research and regulatory compliance with confidence. Partner with us for a seamless journey towards scientific and regulatory success.

For more information on our services and how we can support your medical writing needs, visit Navitas Life Sciences.