Oncology clinical trials have the lowest success rate of all indications, particularly late-stage trials that cause sponsors huge losses if they fail. A successful oncology study requires strategic planning from the outset of the trial, knowledge of the challenges and opportunities specific to cancer research and consideration of the following options to improve the odds of having a successful trial outcome:

1. Innovative trial design and master protocols (i.e., basket, umbrella and platform trials)
2. Using newly accepted endpoints
3. Finding/measuring surrogate biomarkers that your product affects and correlate surrogates to beneficial clinical outcomes
4. Adaptive trial designs to add flexibility and control cost
5. Supplementing with economic benefit data to speed up market acceptance
6. Determining optimal number of sites and using rigorous site selection processes
7. Applicable FDA expedited approval programs and designations whenever possible (e.g., Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review)

There is an urgency to develop novel anticancer therapies, and we are here to help. Our experts will work alongside your team to navigate trial complexities at every stage of your oncology study. We offer a full range of clinical trial and regulatory services to fit your product development needs.

Our Experience:

• 15+ years of oncology experience
• 70+ clinical projects
• Product types: Drugs (NCEs, botanicals, biologics, cell therapies and gene therapies), devices and diagnostics
• Clinical trials: 40+ (Phase I-IV), 300+ sites, 2,000+ patients; proof of concept through FDA marketing approval
• Regulatory services: Multiple approved IND applications, one approved NDA, multiple orphan drug designations, one approved IDE application, one approved ANDA and two approved PMAs
• Full-scope and targeted-scope projects

Therapeutic Indications:

• Advanced/refractory solid tumor(s)
• Breast cancer
• Cervical and vulvar cancer
• Colorectal cancer
• Cutaneous squamous cell carcinoma
• Esophageal cancer
• Gastrointestinal epithelial cancer
• Giloma
• Head and neck cancer
• Leukemia’s (acute/chronic, myeloid/lymphoid)
• Lung cancer
• Metastatic melanoma
• Myeloma
• Nasopharyngeal cancer
• Non-Hodgkin’s lymphoma
• Ovarian cancer
• Pancreatic
• Prostate cancer
• Rectal and anal cancer
• Renal cell carcinoma
• Soft tissue (sarcoma)

Related Indications:

• Breakthrough cancer pain (BTcP)
• Companion diagnostics (e.g., in vitro diagnostic device)
• Development of cancer prognostic markers
• Development of predictive biomarkers (genetic/molecular predictive of drug response)
• Imaging agents and imaging devices for tumor biopsy analysis
• Immune function improvement
• Protection from radiation treatment damage
• Tumor genetic sequencing