Clinical Research

Lifetree Clinical Research Center of Excellence is a carefully designed 60 bed investigative unit that supports the precise execution of analgesia, abuse liability, neuroscience and phase 1 research.

Lifetree Clinical Research, Lifetree Pain Clinic and Lifetree Center for Neuroscience Research are strategically integrated in a seamless 25,000 square foot state of the art facility. Our clients benefit from the consistent and focused MD investigator oversight for each and every project.

Lifetree’s Research Center has been FDA audited in 2004 and most recently in January of 2010 with no 483’s! Lifetree’s attention to subject safety, pristine data and adherence to our client’s timelines are among the many reasons why our clients return to work with Lifetree.

The Lifetree Research Center offers experienced MD Investigators and Sub Investigators, Research Pharmacist, and Certified Research Coordinators that are analgesically trained with a deep understanding of the importance of Inter-Rater Reliability. Our staff is experienced in a variety of validated tools such as VAS, Categorical Scales, NPRS, cognition testing, Quality of Life, Cole ARCI and Mini Mental to just name a few.

Lifetree’s competency based documented Training Program includes NIH, GCP, ICH and FDA regulations. All coordinating staff are also required to complete BLS and ACLS certifications. Our research staff are keenly aware of the issues surrounding proper Informed Consent Process and therefore spend the time necessary with each potential research subject to ensure the subjects fully understands the information contained in the ICF as well as their obligations to the protocol required assessments once the subjects agree to study participation. Ethical treatment and subject safety are among Lifetree’s primary concerns.

Lifetree Clinical Research Center is a 60 bed facility and is configured to support timely, efficient data collection while allowing our on-site trained investigators access to oversee the important safety aspects of each study participant. Our research subjects are housed in private or semi-private rooms where no visitors are allowed, however, each room is equipped with wireless internet access to allow research subjects to surf the internet, send emails and catch up on home work on a private, secure system. Subjects have satellite TV, VCR, and DVD players set up in each room or in a large multipurpose room that may also be used for meals, games and other day time activities.

Lifetree boasts a State-of-the-Art Welch-Allyn® Propaq® wireless telemetry monitoring system with a central station computer where subject data is relayed back to a main computer. This system is capable of continuous telemetry, ECG, apnea, pulse oximetry, video monitoring including internal mapping of subject rooms, prints outs of annotated reports in real-time and stores monitored data for 96 hours. An added value of this system is the ability to be programmed and customized to subject mode settings that can be set per protocol specifications.

Additional features of our Research Center are secured access with surveillance monitoring, temperature controlled limited access drug room with capabilities to store and handle schedule I-IV compounds, research pharmacist, laboratory with trained lab technicians, alarmed and generator backed-up refrigerator and freezers, crash cart, AED, on on-site operating room with fluoroscopy, anesthesia support for acute and chronic pain procedures that include implantation of experimental devices.

Among the unique attributes of Lifetree is the diversity of our Research Center of Excellence which includes Abuse Liability research in specialty populations, CSF Sampling, Cold Pressor and Polysomnography. The distinction of our Research Center is built around our Clinical and Research Thought Leaders.

Recruitment Services:

Lifetree Clinical Research ® has a Team of dedicated Participant Recruiters assigned to each Project Team. These highly trained individuals manage a database of over 12,000 research subjects. The database includes approximately 5,200 healthy volunteers. Prior to kicking off screening activities for your trial, the Lifetree Recruiters generate and obtain IRB approval of project-specific ‘Phone Screening Forms’. This ensures that all potential subjects are provided with consistent early information about your trial. The Lifetree Recruiters are trained to take detailed information via telephone interviews to evaluate the appropriateness of scheduling the potential participant for a Screening Visit. The Lifetree pre-screening process is specifically designed to minimize the screen fail rate of your project. Our greatest advertising tool in this population is word-of-mouth. As an added value, Lifetree has a Subject Referral Policy that supports referrals from our previous participants which increases our database of healthy volunteers on a daily basis at no cost to our clients.

Whatever your clinical research needs contain, Lifetree Clinical Research® is your indispensable partner.

Our Therapeutic Expertise Is In:

Phase I Studies

• First in Human
• First in Patient
• POC
• DDI
• BE/BA
• SAD/MAD/MTD

Abuse Liability in specialty populations

CSF Sampling

Phase II-III Studies

• Analgesia
• CNS
• Ophthalmology

Novel Pain Model Development