Where We Deliver Value
Research & Development
We take a multi-faceted approach to supporting your Research & Development projects by balancing a focus on improved productivity, reduced costs, and goal-oriented planning, while engaging the top-level project managers, subject matter experts, and cross-functional core team leadership you require.
Quality, Regulatory, & Compliance
Our consultants help our clients navigate compliance and regulatory roadblocks. From the early planning phases to more recovery-related projects, we orchestrate Corrective and Preventative Action (CAPA) workstreams, address regulatory citations and 483 warning letters, and implement protocols that reduce manufacturing downtime. We also prevent and correct issues to support new product development and lifecycle management.
Clinical Operations
We specialize in providing professional industry experience to fill clinical skill gaps and bring you closer to success across both clinical development and clinical operations. Whether you seek clinical trial physicians, clinical leaders responsible for building protocols, or a team of clinical research associates, our experts are ready and available to meet your needs and exceed your expectations.
Manufacturing & Supply Chain
Navigating the complex and ever-shifting landscape of global manufacturing and supply chains is a fluid, easier process with the support of our experienced project leaders and Subject Matter Experts. Our team members have supported pharmaceutical and medical device leaders as they drive efficiencies, tackle challenges, and realize opportunities across this complicated and highly regulated line of service.
Corporate & Commercial Operations
We provide uniquely calibrated assistance to our clients as they execute KOL tool implementations and upgrades, manage enterprise-wide organizational changes, and bolster capabilities in key therapeutic areas. These efforts allow us to provide critical support for our clients as they aim to demonstrate value to healthcare providers and derive intelligence from stakeholder insights.
Biometrics
Our Biometrics services provide pharmaceutical, biotech, and medical device companies with biostatistics, statistical programming, and data-related services for phase I-IV clinical trials, pre-clinical studies, and post-marketing data analysis & reporting services. As the premier submission support partner, we offer a strong consultant pool, technical expertise, and exceptional product knowledge spanning support of over 30 major NDA and sNDA submissions in multiple therapeutic areas and indications over the last 15 years.
Scalable, Flexible Solutions
We offer a selection of unique approaches designed to leverage our expertise for your success along with some of the strongest subject matter experts in the field.