Translating research into practice through submission-ready documentation
Our highly qualified and experienced medical writers traverse clinical and non-clinical data, interpret findings and deliver clear and concise documentation.
Working closely with our multidisciplinary team, Accleagen’s writers harmonise clinical knowledge, compliance requirements and patient-centricity to produce all artefacts required for a successful study.
- Strategic development of Regulatory compliant documentation
- Drug and Biotech Clinical Study Reports in accordance with ICH Guideline E3
- Clinical Study Protocol and Investigators Brochure
- Patient Information and Informed Consent Forms (PICF)
- Study Manuscripts for Publishing Purposes
- Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR) for Regulatory Submission
- Global Submission Ready documents for inclusion in IND, IDE, NDA or BLA applications
How we work
Enabling successful approvals
We produce comprehensive documentation, aligned with essential regulatory guidelines, that supports ethics and regulatory approvals.
Clear and collaborative study protocols
Our medical writing team works in close collaboration with sponsors to craft protocols that are easy to understand and maximise the data that supports the quality and efficacy of your technology.
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Patient-centred information and consent statements
Providing participants with clear and unbiased information, ensuring full and informed consent.
Arming you with the right information at study closure
Study reports that capture all essential and meaningful information, including safety analysis and pharmacokinetic data.
Medical writing
case studies
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