Explore our services
Therapeutic Expertise
Development Plan
Phase I
Phase II-III
Regulatory Submission
Post-LAUNCH Studies
Therapeutic Expertise
You need a team that understands the nuances of your therapeutic area and indication. We have a deep bench of therapeutic experts who deliver valuable scientific insights on the clinical and commercial landscape for your therapeutic area. Our experienced study teams know what to expect and how to help you reach success.
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Therapeutic Expertise
DEVELOPMENT PLAN
A comprehensive clinical development plan will provide a roadmap for key activities – including cost and timeline factors – for investors and key stakeholders. We can help you understand your product's specific landscape and market, so you can develop a strategy that will effectively translate into trial execution – avoiding costly amendments down the road.
Development Plan
PHASE I
Establishing a collaborative, trusting, and transparent working relationship from the start is one of our primary objectives when working with customers in Phase I studies. To achieve that goal, we listen to your needs and pull together a project team with both early clinical development expertise and the therapeutic and indication-level expertise and scientific knowledge necessary to help navigate through the regulatory and clinical development process of a first-in-human study.
Phase I
Phase II-III
Remove the complexity in getting to your next milestone. Our therapeutically aligned project teams receive specialized training on the unique needs of our biotech customers and follow customized SOPs. Each dedicated project lead also has industry-leading data, analytics, technology and expertise at their fingertips, and the knowledge to know how, and when, to pull in those resources to help our customers develop innovative solutions to complex problems.
Phase II-III
REGULATORY SUBMISSION
Remove the complexity in getting to your next milestone. Our therapeutically aligned project teams receive specialized training on the unique needs of our biotech customers and follow customized SOPs. Each dedicated project lead also has industry-leading data, analytics, technology and expertise at their fingertips, and the knowledge to know how, and when, to pull in those resources to help our customers develop innovative solutions to complex problems.
Regulatory Submission
POST-LAUNCH Studies
Regulatory authorities are now increasing opportunities for you to provide real-world evidence of your products’ safety and effectiveness. This changing environment can make your products more available to patients. Increase the effectiveness and efficiency of your safety studies. Leverage our innovative methods for RWE study design and execution, combining secondary and primary data directly from patients and physicians.
Post-LAUNCH Studies
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