Medical Writing
Empowering you and your innovation, our team of scientists share knowledge and bring extensive experience in a wide range of global clinical research guidelines to tell your product’s story and help realize the full potential of your science.
Caidya delivers a perfectly balanced medical writing service with the flexibility, quality and experience needed when crafting documents essential to the success of your clinical journey.
Long-term strategic support
The flexibility of our medical writing team means we can offer long-term strategic support or service stand-alone projects.
We deliver truly personalized experiences that mold to your need, operating with our own Standard Operating Procedures (SOPs) or drafting in line with your templates and style guides.
Our ownership mindset means we’re committed to your success from the moment our partnership begins, bringing our knowledge to consult and guide your approach and support with delivery across:
Study-related documents
- Study Design
- Clinical Study Protocol (CSP) including gap analysis, full CSP, CSP Amendments
- Core Informed Consent Form (ICF)
- Clinical Study Report (CSR) & CSR Narratives
- Devices: CIP, CIR, CEP, CER, SSCP
Public disclosure
- Public Disclosure Versions: CSP, CSR, Statistical Analysis Plan (SAP)
- Peer-reviewed publications
- Lay Language Summaries
Submissions & development plans pre, during, and post-trial
- IND Support
- Investigator’s Brochure (IB)
- Developmental Safety Update Report (DSUR), Periodic Benefit-risk Evaluation Report (PBRER)
- eCTD M2.5, M2.7, Integrated Summaries of Efficacy (ISE) and Safety (ISS)
Ensuring total consistency is essential when drafting your most crucial documentation. We assign one leading author per document while ensuring multiple contributors are on-hand to deliver against your timelines.
We achieve the highest quality across every piece through proactivity, high-performance authoring and integration of appropriate functional reviews and quality assurance as standard, with all documents peer-reviewed.
Personalized clinical research services
Across every stage of your clinical journey, we’re by your side to help you advance through clinical trials to get your therapy to patients and help bring your science to life.
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