Contexts of use

From trial design to scientific reporting and regulatory interactions, a drug development program will present itself through several contexts of use.

Reducing uncertainty

“Through experience, we are well aware of the swift pace and the many variables to consider before every decision in a drug development program.”

With the right support, you can reduce risk and uncertainty along the process, aiding decision-making in a way of working adapted to the context of use.

  • We know of the challenges in leveraging and analyzing disparate clinical data to better understand both drug and indication properties.
  • We understand the importance and challenges of establishing collaboration across disciplines.
  • We have helped clients achieve effective decision-making regarding special considerations in trials or analyses involving special populations.
  • We are familiar with the short turnarounds and many stakeholders involved in preparing for the end of Phase II meetings, filing after Phase III, or drafting a pediatric investigation plan (PIP).

Contexts of use

Every trial has its challenges, and we stand ready to complement teams’ capabilities to overcome these obstacles.

Collaborations to support and inform strategies and decision-making.

Some populations, like pediatrics, patients with renal impairment, obese patients or others, require special attention and often dedicated trials.

C-QTc, DDIs, IVIVC, BE and BS, immunogenicity and other special considerations require special knowledge and methods, but have all in common to be able to be elucidated by leveraging modeling capabilities.

Interactions such as consultations or Phase lll submission, end of Phase ll meetings, or others can provide great insights to the drug development team.