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Fervor Health Solutions

Regulatory & Medical
Writing Services

Your clinical trial documents tell the true story of your study. Our proficient team of medical writers has the experience and expertise to deliver clear, accurate, regulatory-compliant materials that fully support your clinical trial.
What’s more, when you combine a superior team with a streamlined process, you receive a cost-effective solution that saves your study time. Our process allows writers to maximize efficiency by easily accessing information and collaborating with key stakeholders and project team members. Once your materials have been expertly crafted, our strict clinical, medical, and statistical review processes ensure you receive ICH and GCP-compliant materials on deadline.

Fervor Regulatory and Medical Writers work collaboratively with internal experts in regulatory operations, medical, clinical, biostatistics, clinical data management, and other departments to produce documents that reflect the regulatory, clinical, and scientific expertise and integrity of the entire organization. Our experience helps us deliver a portfolio of regulatory and medical writing services to address the needs of every clinical research project including:

Integrated product development plans
IBs, ICFs and other study tools
Protocols and CSRs (All phases)
IMPDs and Clinical Trial Authorizations
Regulatory meeting briefing packages
DSURs and
PSURs
RMPs and Safety Narratives
Pediatric Investigation Plans
CEPs and
CERs
Interim data summaries
NDAs / BLAs /
MAAs
Abstracts and manuscripts
Integrated summaries of safety (ISSs) and efficacy (ISEs)
Data and safety monitoring board (DSMB) charters and reports

WE MAKE BEAUTIFUL themes

Our document content reflects accuracy through meticulous quality control processes Fervor’s internal quality control (QC), provided by our document preparation and review standard operating procedures, ensures regulatory compliance for the regulatory and medical writing team’s documents.
In addition, our biostatistics and data standards teams are considered industry leaders in the regulatory requirements for data collection and presentation to regulatory authorities, and, consequently, we are called upon frequently to assist with the following components of regulatory submissions:
Define files (PDF or XML)
Readme file
Integrated data sets
(for ISE and ISS)
Integrated clinical and statistical analysis plans
Clinical Data Interchange Standards Consortium (CDISC) (Study Data Tabulation Model [SDTM] and Analysis Data Model [ADaM])
Compound analysis, Exploratory
Domain & study analysis databases
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