Medical writing
We understand the importance of good writing. Our goal is to produce concise, substantive, and polished clinical documents.
Our writers have the writing skills, experience, relevant medical and scientific educationto produce the requested medical writing in a timely manner. All of our deliverables undergo a rigorous copy-editing and QC review to ensure they are read well, comply with regulatory guidelines and accurately interpret the study results.
Some clinical trial clients may not have access to a local IRB/EC. There may also be compelling reasons for an institution not to interact directly with the local IRB/EC and instead turn to a CRO instead. PRU can attend to all requests and follow up with IRB /EC entities until final outcomes are met.
We offer appropriate, validated and documented services in data management and biostatistics mainly on non-interventional clinical studies or regional phases IV studies.
Our team is involved from the start of the project and customize database to project specificities and source data for achieving the study objectives.
Our experienced data management staff can provide:
- Protocol review
- CRF design
- Database / eCRF preparation
- Data entry (single or double entry)
- Data review / Query management
- Medical review
- Export of entered and analyzed data (SAS, Excel format)
- Sample size / power calculations
- Statistical Analysis Plan creation / review
- Statistical analysis
- Archiving
Pharmacokinetics and statistical evaluation
Study Reporting (CTD) and (eCTD)
