We are focused on serving the biopharma/biotech market and strive to be a consultative and proactive oncology CRO partner. Our customized solutions are designed around the individual needs of each of our biopharma clients.
Our people, company culture and can-do attitude, along with our unique combination of oncology and rare disease expertise and technology, differentiate us from our competition.
We seek to be more than simply a vendor, by adding value to the clinical development of our biopharma client’s emergent therapies. We pride ourselves on our commitment to delivering high-quality service.
Our Oncology Proposition:
- Scientific and operational expertise in complex trial designs, i.e., adaptive, basket, umbrella
- A team with 100% oncology and cell therapy experience
- Dedicated teams to early and later phase trials
- Understanding the risks and contingencies to delivering any project on time
- Technology enabling flexibility and faster decision making
- Proactive partnership approach
- Close communication between our team, sites and sponsor
Our Work In Complex Trial Designs
We excel in delivering trials evaluating the latest advances in investigational therapies. Our team is well versed in a plethora of trial designs including dose escalation both biomarker based and not, blind/double blind, cross over trials and others. Our experience enables our ability to help sponsors develop or deliver a personalized approach to medicine and an increased efficiency in investigational product development.
Examples of Personalized Medicine designs:
- Interaction designs: defined as enrollment of marker + and – patients with randomized to targeted vs. non-targeted therapy
- Enrichment designs: defined as enrollment of marker + patients only, with or without randomization
- Adaptive enrichment designs: Defined as adaptable enrollment during trial from full population to patients who seem to benefit from product under study
- Marker strategy designs: defined as patients randomize to treatment strategy: based on biomarker status vs. not based on biomarker status (e.g., physician’s choice)
- “Master protocols”
- Basket trials, umbrella trials, platform trials, etc.