David Browning

Background

About David Browning

Telos Clinical Research, LLC is an oncology trial management and consulting organization focused on Phase I and II clinical trials in the US, Europe, Mexico, Australia, and South Africa. We specialize in complex dose-escalation and dose-expansion studies of novel agents (targeted therapies, immunotherapies, and combination therapies) in cancer patients. The Telos team consists of highly experienced oncology researchers who understand the challenges of managing dose-escalation safety issues, patient cohorts and slots, compliant collection of tissue and blood samples for pharmacokinetics (PK) and correlative lab studies, and timely data collection for escalation decisions. Because little is known about the drug in Phase I, undetected problems can significantly impact the compound’s development in later phases. With so much at stake, focused planning and execution of early phase studies are critical. The Telos’ team averages over 15 years of oncology drug development experience working in industry and at investigative sites. We can provide a single consultant or a team of consultants to help plan and execute your Phase I and II studies. We can also effectively and efficiently manage your studies by supervising your CRO on your behalf or directly conducting the trial for you. Telos Clinical Research’s team of expert consultants can support all aspects of your early development trials or just fill in the gaps where needed: • Investigational New Drug Applications (IND)/ Chemistry, Manufacturing, and Control (CMC) • Regulatory strategy and FDA representation • Registered US FDA agent • Protocol design, development, and writing • Vendor selection and management • Pharmacokinetics design and analysis • Site start-up services (IRB/EC, contract & budget negotiations) • Project management • Clinical monitoring • Safety reporting • Medical monitoring • Data management • Biostatistics • Clinical Study Report (CSR) writing