Strategic Drug Development Services

Lifetree Clinical Research seeks to partner with companies in both the biotechnology and pharmaceutical sector in an effort to become an indispensable drug development partner. Our Clinical and Regulatory Thought Leaders at Lifetree Clinical Research® provide clients with a proven track record of successful drug development in the US and EU with multiple INDs in pain. Our full IND services offer preclinical compound assessment, evaluation of animal pharmacology, preparation for first in human trials and document preparation. Lifetree has direct experience with the current regulatory environment and review division personnel in Alternative Formulations, Alternate Routes of Delivery, Combination Drug Products, and Abuse Liability.

Lifetree is uniquely integrated with a large multi-disciplinary chronic pain clinic and our newly founded Neuroscience division that affords Lifetree unparalleled access to patients with real-world pain and neuroscience conditions.

At Lifetree we have the ability to design and development programs to best reach the market in the prevailing regulatory environment: Phase I first in human trials, first-look/surrogate efficacy endpoints, experimental pain models, and proof of concept programs.

At Lifetree, we believe that every protocol must make sense and be part of a larger strategy for regulatory and marketing approval. Protocols are designed as part of programs, which should identify and integrate the characteristic strengths and weaknesses of each compound or device and the needs of the marketplace.

Novel Pain Model Development

Lifetree staff have aided in pioneering the development of the post-operative bunionectomy model and the associated methodology that has been presented to the FDA and is now widely used in the analgesic drug development process. Lifetree understands the ever changing drug development market and the need for novel pain model development and progress. The Lifetree Clinical Research® Center of Excellence facility is designed to offer cutting edge technology and methodologies to provide our clients with innovative clinical trial models.