Change the game in drug development
We combine clinical pharmacology with model-informed drug development to help you make decisions and achieve program success. The involvement of clinical pharmacology with the support of MIDD approaches will help you to achieve this objective.
Our Clinical Pharmacologists are key members of cross-functional drug development teams. We work to optimize clinical pharmacology programs and dosage through our thorough understanding of drug mechanism, pharmacokinetics, pharmacodynamics and MIDD approaches. From lead selection through late-stage development, the experienced clinical pharmacologists at Certara work with sponsors to minimize risk and leverage quantitative and regulatory science to efficiently bring drugs to market. Our Clinical Pharmacology experts are:
- Experienced thought leaders who prioritize critical needs to ensure you have the right data to enable decision making and can lead cross functional teams to interpret the data collected.
- Former regulatory reviewers who consider the latest developments in regulatory requirements to develop optimal strategy.
- Quantitative Clinical Pharmacologists who work with internal and external model informed drug development partners to critique and develop quantitative strategies to fill knowledge gaps and justify dose.
- Authorities in areas such as oncology, pediatrics, complex biologics and rare diseases.
What our clients say:
“What I love most about working with Certara is their experience and expertise as well as their collegiality.” – Executive Director of Clinical Pharmacology at a Japanese public pharmaceutical company
“Certara’s team thinks outside of the box. They also move quickly.” – Director at German-based large pharmaceutical company
Support when you need it how you need it
We are an extension of your team. Whether you need strategic advice, a clinical pharmacologist expert to brainstorm with or to support your programs, we will provide you with the right level of experience.
Our broad range of clinical pharmacology services for full program or study level support can be ideal for both small biotech and larger pharmaceutical companies looking for clinical pharmacology support on a full- or part-time, or ad-hoc basis. Our consultants bring a large and diverse range of expertise in all therapeutic areas, as well as global regulatory expertise across all stages of development.
We can also provide bandwidth support to allow your employee’s the ability to focus on high priority workstreams or fill in knowledge gaps with our senior subject matter experts.
Develop a clinical pharmacology plan
Starting with a gap analysis, our clinical pharmacology experts can create and outline a clinical pharmacology development plan that integrates nonclinical, DMPK, pharmacokinetic, pharmacodynamic, and clinical data with seamless model-informed approaches. Our internal pharmacometrics and SimCYP groups enable seamless integration to perform stand-alone model-informed support or supplement existing efforts.
We are confident in our recommendations and know what is needed, when to have it, and how clinical pharmacology and modeling can be leveraged throughout your program to ensure you have what you need to make decisions and achieve global regulatory success!
Extensive Regulatory Expertise
The Certara Clinical Pharmacology Team includes former FDA, MPA and MHRA clinical pharmacology reviewers, in addition to deep and recent global regulatory experience provided by senior consultants who have interacted with FDA, EMA, PMDA and other global regulators in their former roles and current program experience.
We can ensure you are asking the right questions at the right time and provide robust justifications to maximize the probability Regulatory success for your approaches.
Wide Range of Clinical Pharmacology Offerings:
- Clinical Pharmacology Gap Analyses
- Clinical Pharmacology Development Plan
- Human Dose Projections & translational modeling
- FIH/FIP study design and dose escalation strategy
- Phase 1/2/3 study support
- Clinical Pharmacology Representative for Study and Project Team
- Regulatory Support
- Due diligence for licensing/investor support
- PK and PD data analysis and modeling
- Integrated Modeling Strategy (popPK, ER, PBPK, QSP etc).
- Interpretation and application of PK results and modeling analyses
- Dose selection and justification
- cQT, TQT and QT waiver support
- Clinical Pharmacology Study support including:
- Drug interactions
- Food Effect
- Organ Dysfunction
- Formulation BA and/or BE
- Ethnic bridging
- Pediatric strategy
- PK study analysis and reporting
- Module 2.7.1/2.7.2 strategy and writing
- Clinical Pharmacology writing (protocols, CRS, IB, publications etc)
- Dose Optimization (eg. FDA Project Optimus for Oncology drugs)
Our global team of experts
Certara employs over 46 clinical pharmacologists with diverse backgrounds in biotech, pharma, CRO and former regulators. We have scientists in North America, Europe, and APAC with broad therapeutic and technical expertise.
Our Clinical Pharmacologist Leaders