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CNS Medical
Writing Services
Turning Complexity
into Clarity
At CRC, our teams transform complex data into clear, compliant, and compelling narratives. Our Medical Writing team delivers regulatory-ready documentation with precision and expertise—ensuring that every submission reflects the highest standards of accuracy and scientific integrity.
Led by Ph.D. and Pharm.D. professionals, our writers combine deep scientific understanding with regulatory insight to produce documents that meet agency expectations and support timely approvals. Whether developing a Clinical Study Report (CSR) or preparing an IND/NDA submission, CRC helps sponsors communicate results that are both clear and credible.
INTEGRATED COLLABORATION
ACROSS EVERY FUNCTION
CRC’s Medical Writing team works seamlessly with Biostatistics, Data Management, and Quality Assurance to ensure every document is accurate, traceable, and aligned with the study’s scientific intent. This cross-functional collaboration guarantees that data are presented clearly and consistently across submissions and publications.
By uniting statistical rigor with medical insight, we help sponsors deliver documents that inspire confidence in both reviewers and readers.
OUR MEDICAL WRITING SERVICES
01.
Clinical Study Reports (CSRs)
CRC develops comprehensive Clinical Study Reports that accurately document study findings and statistical results. Following International Council for Harmonisation (ICH) E3 guidelines, our CSRs provide the clarity and consistency regulators expect while showcasing the scientific integrity behind your trial data.
02.
Clinical Protocols
Our writers develop rigorous Clinical Protocols in accordance with ICH E6(R3) Good Clinical Practice. Using our deep understanding of clinical study design, we craft protocols that clearly communicate critical study elements including trial objectives, participant selection criteria, clinical procedures, and study endpoints to the investigators and site team, Institutional Review Board (IRB), and regulatory agencies. Well-written protocols support correct study conduct, safeguard participant safety, protect data integrity, and ensure effective site engagement.
03.
Investigator Brochure Compilation & Updates
CRC compiles and regularly updates Investigator Brochures, ensuring all product and safety information is up to date. These documents serve as a vital reference for both investigators and regulatory authorities, allowing a balanced assessment of risks and benefits associated with your investigational product and ensuring alignment on your CNS trial program’s objectives and methodologies.
04.
IND & NDA Development
CRC supports Investigational New Drug (IND) and New Drug Application (NDA) development, preparing detailed, compliant submissions that facilitate efficient review and approval by the FDA and other global agencies. Our experience with CNS indications ensures precision in how efficacy and safety are presented.
05.
Manuscripts & Abstracts
Our writers collaborate with your research team to craft manuscripts and abstracts that communicate key findings to the broader scientific community. Each piece is written with clarity, accuracy, and adherence to journal standards—helping you build recognition for your therapeutic advancements.
06.
Regulatory Response & Submission Support
When agencies request clarification, our writers are ready. CRC provides regulatory response documents and submission summaries that address feedback clearly and concisely—supporting faster resolutions and smoother approval pathways.
07.
Full ICH-Compliant Documents
CRC produces full ICH-compliant documents that meet international technical requirements for pharmaceutical registration. Every document adheres to the latest ICH guidelines, ensuring readiness for regulatory review worldwide.
Why Sponsors
Choose CRC for
Medical Writing
Every word matters in CNS drug development. CRC’s medical writing services support sponsors from early clinical phases to pivotal trial publications. Our writers specialize in neurology, psychiatry, and analgesia trials, ensuring that complex neuroscience data are translated into concise, compliant deliverables.
Our Medical Writing experts collaborate closely with clinical teams, statisticians, and quality assurance professionals to align every document with your protocol, data outputs, and regulatory requirements, and always keeping your drug label in mind. The result is content that not only meets the highest standards—but advances your science.
Key Benefits:
- Experienced team of Ph.D. and Pharm.D. professionals
- Specialized expertise in CNS trials across neurology, psychiatry, and analgesia
- Proven success developing INDs, NDAs, and ICH-compliant reports
- Consistent alignment with FDA, EMA, and ICH standards
- Seamless collaboration with clinical and statistical teams for accuracy and cohesion
get in touch
Ready to partner with a CNS CRO that delivers precision, compliance, and clarity in every document?
Contact CRC to learn how our medical writing expertise can strengthen your next submission.