Scientific Affairs

Protocol Development draws on the expertise of clinical science, medical affairs and biostatistics in developing protocols that test the appropriate endpoints of and meet regulatory requirements for pharmacokinetic, pharmacodynamic and clinical efficacy studies. Our teamwork in protocol development has helped us cultivate an in-depth understanding of drug development trends. This allows us to tackle new indications and products and develop innovative designs in topical/transdermal bioequivalence studies.

Biostatistics fields a team of experts who are part of every clinical study, contributing from design through final study report. Novum biostatisticians and SAS Programmers are experienced in developing Statistical Analysis Plans (SAPs), along with the programming required to produce final statistical tables, listings and figures (TLFs) included in study documents and final clinical study reports. The TLFs are subjected to a high level of quality control within the team. In addition, Novum’s biostatistics team has extensive experience in the unique statistical methods utilized to analyze more complex bioequivalence studies, as well as clinical endpoint studies in support of regulatory submissions.

Biostatistics services include:

  • Input into Study Design and sample size calculations
  • Consultation during protocol development
  • Generation of randomization schemes
  • Preparation of Statistical Analysis Plans (SAPs)
  • SAS Programming of Tables, Listings and Figures (TLFs)
  • Quality Control of TLFs
  • Preparation of stand-alone Statistical Reports
  • Input into the Clinical Study Report (CSR) for regulatory submissions to FDA, EMA and TPD
  • Preparation of CDISC data sets (SDTM and ADaM)
  • Attendance of senior personnel at regulatory meetings

Medical Writing is a collaboration of our report writers, clinical scientists, project managers and biostatisticians. They understand the importance of this phase of the clinical research process and are skilled at interpreting the data and conveying the results of the study in a well-written, informative document.

All reports are structured for submission to global regulatory agencies. Our ongoing communication with the FDA ensures that we are preparing reports to FDA standards for NDA/ANDA submission. In addition to FDA submissions, we are experienced in Canadian and European Union submissions.

Bioanalytical Management
Novum does not operate or directly contract with third-party bioanalytical laboratories. However, we actively manage the analytical process by coordinating the communication, delivery of samples and receipt of data for each study. With decades of experience and relationships with analytical providers, Novum can manage this aspect of your project seamlessly.