Interventional Studies
Building a larger body of evidence for a product requires the right experts
Specialized knowledge and dedicated resources are needed to successfully navigate the ever-evolving, peri- and post-approval research requirements of regulators and health authorities.
Our team of dedicated experts who specialize in peri-and post-approval interventional studies can help you inform appropriate clinical practice, support optimal commercialization and market access, and address specific post-approval regulatory and health authority requirements.
Seamlessly navigating the transition to peri- and post-approval research
Our interventional study experts can help you overcome the challenges associated with:
- Bridging the gap and leveraging the data and insight generated and the patients evaluated during pivotal clinical trials when transitioning to post-approval studies
- Generating data to address peri- and post-approval evidence gaps
- Meeting health authority requirements for post-marketing safety surveillance
- Optimizing data flow to answer key asset/brand questions in a timely manner
- Informing appropriate clinical practice and product use, and ensuring data are available to answer medical communication queries
- Enabling optimal commercialization and market access
- Validating new dosing or models of administration
- Enhancing exploratory analyses through innovative collaborations with scientific experts
Study types
- Phase IIIb/IV studies
- Expanded access and post-trial access programs (EAP/PTAP)
- Open-label extension (OLE) and rollover studies
- Post-marketing commitments
- Lactation/placental transfer studies
- Pragmatic/adaptive trials
- Investigator sponsored/initiated trials (IST/IIT)
Customized studies executed by a dedicated global team
Our global team of experts and operations professionals has deep country-level knowledge of ethical and regulatory requirements, patient privacy legislation, investigator grant policies, academic and site networks, patient associations, national health databases and local health care systems that allows us to customize each project for successful execution.
- Extensive experience – Dedicated operations, regulatory and global clinical supply teams with experience across ~116,000 patients and ~15,000 sites globally in the past five years
- Specialist medical affairs team – Significantly beat industry benchmarks in study startup and patient recruitment time when working under an early engagement partnership model
- Therapeutic area experts – Capabilities across a wide range of indications and ability to leverage a wide network of clinicians and global operations professionals
- Integrated partnership model – Flexible and proactive operating and governance model customized to unique needs
- Innovative methodologies – Application of innovative methods (e.g., pragmatic studies) resulting in optimal study design, endpoint selection and statistical analyses
- Expertise in study design and protocol development – All studies governed by a scientifically robust protocol that is reviewed and quality controlled by an in-house, industry recognized research team
