Real-world clinical evidence in human therapeutics

We work with our life sciences clients on scientific strategy for late-stage development.

We support our sponsors in developing study portfolios of strategic relevance. We assist them in their due diligence work. We design studies of the highest scientific and technical merit – yet strategically aligned. We develop dissemination plans that position studies and products, bring out the innovation, target stakeholders, and enhance the scientific and public trust image of our clients – diverse in scope, content, mode, timing and staging, if not geography.

We do not implement studies in terms of site management, approvals, contracting, staff training, monitoring, and data acquisition and entry, but work with our clients’ specialized partners – yours or ours. We coordinate, communicate, and problem-solve during the study. We come back in at the time of analysis. We implement the publication plans.

Many of our studies have been observational studies of treatment patterns and outcomes in the “real world” of daily clinical practice. Pharmacovigilance is embedded.

We emphasize merging the scientific with the strategic: scientifically rigorous studies that get presented at major congresses and published in major scientific journals; that contribute to the evidence base; that translate into patient care; that inform and sustain corporate strategy; that are cost-responsible; and that improve access and equity to health care.

Why this “real world” focus?

Randomized controlled trials tell us what outcomes to expect when a treatment is given: the efficacy signal obtained from “perfect” patients cared for by “perfect” clinicians in “perfect” centers with “perfect” research staff following “perfect” treatment protocols. These conditions are critical to get the purest possible efficacy signal – to make the most informed approval decision about a treatment.

These perfect conditions cannot be emulated in the real world. Any deviation in conditions can lead to deviations in outcomes – worse or better. The emphasis shifts from a drug to a treatment, from a condition to a pattern, from a narrow endpoint to a broad spectrum of outcomes – from efficacy to effectiveness.

We model how variability in treatment patterns and context is associated with variability in outcomes – and the factors that mediate this process. Instead of merely evaluating effectiveness (“does the treatment work?”), we address the equally important questions of “when does the treatment work, and when not?”, “what influences whether the treatment works?”, “why does the treatment work in some patients but not in others?”, “why does the treatment work with some clinicians but not with others?”, and “why is the treatment tolerated by some patients but not by others?” In this process, we try to complement evaluating patient-related determinants of clinical outcomes with clinician, center, or other “class” factors.

We draw methodologies, statistical models, and technologies from other disciplines into our work, engaging expert scientists and complemented by a global network of specialists.