Regulatory, Documentation and Reporting
A critical aspect of our responsibility to our clients is to ensure compliance with the changing regulatory guidelines and requirements as well as adapting our services to the emerging trends in submission procedures and technologies. Regulatory support includes Serious Adverse Event (SAE) Reporting, compliant with all regulatory guidelines (FDA and European Regulatory Guidelines).
We prepare clinical research reports and manuscripts. Our complete study documentation includes the research report with summary tables and graphics, clinical data listings and computer output of statistical analyses. Our corporate SOPs and training programs are designed to ensure that the representation and interpretation of study results are consistent with the Protocol, Statistical Analysis Plan and study data. Our scientific and medical writers are committed to ensuring the clarity and accuracy of all reports and manuscripts.
To maintain the investigator’s commitment, to honor timelines and to keep the sponsor informed, MD Trials offers specific reports to keep all parties up to date on the status of the trial.