Medical Writing
For any product in clinical research program to be successful, it is critical that transparent Medical Communication is important.
Our extensive medical writing services are supported by a wide range of knowledge in therapeutic areas and document expertise, customized to meet your project and regulatory requirements and deliver high-quality and scientifically rigorous medical writing deliverables to support your clinical development.
Utilizing practical experience and up-to-date regulatory knowledge, our writers provide expertise in navigating differing global requirements and delivering a collaborative partnership.
Utilizing practical experience and up-to-date regulatory knowledge, our writers provide expertise in navigating differing global requirements and delivering a collaborative partnership.
Our Standalone Medical Writing Services Include:
Study Design
Investigator’s Brochure (IB)
Informed Consent Forms
Protocol and Synopsis
Dossier (IMPDs)
Patient Narratives
Summary document preparation
Investigational new drug (IND) applications
Clinical Study Reports and narratives
Integrated summaries of safety/efficacy (ISS/ISE)
Developmental Safety Update Report (DSUR), Periodic Benefit-risk Evaluation Report (PBRER)
At Sylphid, we have a dedicated team of expertise medical writers with a thorough understanding of regulatory guidelines and comprehensive scientific knowledge to empower your innovations by converting complex scientific information into high-quality, regulatory compliant output by precisely interpreting biostatistics and provide support on Clinical trial documentation, by developing protocols, making amendments, and CSR from initial phase to post approval of the study to pharmaceutical, biotech, medical device clients.
