Scientific Affairs

What We Do

Protocol Development

Protocol Development draws on the expertise of our clinical scientists, medical professionals and biostatisticians to develop protocols that test the appropriate endpoints and meet regulatory requirements for pharmacokinetic, pharmacodynamic and clinical efficacy studies. Our teamwork provides the resources necessary to develop protocols for new chemical entities, new indications and to develop innovative study designs.

Biostatistics

Biostatistics fields a team of experts who are part of every clinical study, contributing from study design through compilation of a CDISC compliant report. Novum biostatisticians and SAS Programmers are experienced in developing Statistical Analysis Plans (SAPs), along with the programming of SDTM and ADaM datasets required to produce the final statistical tables, listings and figures (TLFs). The TLFs are subjected to a high level of quality control within the team. In addition, Novum’s biostatistics team has extensive experience with unique statistical methods to design and analyze complex bioequivalence studies, as well as clinical endpoint studies. In fact, Novum serves on the CDISC Advisory Council, providing strategic advice to CDISC leadership with a platinum membership.

Biostatistical 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) by Novum CDISC certified staff.
  • Attendance of senior personnel at regulatory meetings

Medical Writing

Medical Writing is a collaboration of our report writers, clinical scientists, medical professionals, project managers and biostatisticians. They understand the importance of this phase of the clinical research process and are skilled at interpreting the data and presenting the results of the study.

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.