MDS Pharma Services medical writing staff is trained to evaluate the clinical relevance of safety findings in your studies. They have experience with healthy normal and patient populations. The medical writers can provide integrated services or independent services to fit your development needs. The MDS Pharma Services reporting group uses a standard ICH report format that integrates the safety and PK/PD results in a single study report. We will also work with your formats, and can conform to your specifications for text, tables, figures and listings. This flexibility allows MDS Pharma Services to provide a final study report that is ready for regulatory submission and integration into your document archives.

Early Clinical Research

Phase I-IIa

Bioequivalence Studies

PK/PD

Study Design and Protocol Development

Data Management

Statistical Analysis

PK/PD Analysis

Medical Writing and Reporting

Modeling and Simulation

Consultation