Expanded Access and Disease Registries

Precision Oncology has significant experience in supporting Expanded Access Programs for our sponsors as a pathway for patients to gain access to novel agents during the regulatory approval process.   Our experts can design, implement and manage expanded access programs that provide patients treatment with novel agents while commercial approval is pending.

 

Our services include:

 

• Protocol development

 

• Regulatory document preparation

 

• Site selection and qualification

 

• Rapid start-up support

 

• Electronic data collection

 

• Close collaboration and management of patients through commercial conversion 

 

Precision Oncology also has expertise in conducting longitudinal observational studies within a specific disease. We have conducted trials evaluating up to 1000+ patients from the initial diagnosis of their disease and have followed treatments and response over a 5-10 year follow-up period. These longitudinal observational trials have studied the utility of molecular and genomic profiles and clinical characteristics as predictors of clinical benefit.  Additional goals include the identification of biomarkers to lend new insights into the overall impact of the treatment’s response or relapse as well as potential targets for future therapeutic approaches. 

 

Our expanded access and disease registry experience includes both solid tumors and hematologic malignancies (i.e., Lung, Multiple Myeloma, Lymphomas).