Lifetree Clinical Research® leads the way as a quality conscience investigative clinical research organization with investigators and staff combined clinical research experience of over 30 years. Our analgesic trials consistently achieve superior enrollment performance combined with low query rates. Lifetree investigators and staff have presented and published multiple abstracts and papers. Lifetree Clinical Research® Center offers expertise in the following areas:

Phase I Capabilities:

From our large database of healthy normal volunteers, Lifetree Clinical Research® can quickly enroll almost any specified population into Phase I studies. In addition, we provide rapid regulatory turnaround and shortened IRB approval times to meet your aggressive timelines.

1. Full PK/PD characterizations in plasma, urine, and CSF
2. Polysomnography in a sleep center
3. Safety/tolerability, optimal dosing schedules and MTD in target populations
4. Cardiac safety (QTc) evaluations

Our Phase I service highlights include:

First in Human, Single Ascending Dose
Our team of physicians are on-site and therefore available for rapid response to our research subjects residing in our clinical research site for maximal safety.

First in Human and First in Patient, Multiple Ascending Dose (MAD)
We will help you determine a true Maximum Tolerated Dose (MTD) because we are able to maintain subjects on our Phase I unit for extended periods of time, if the study requires dosing to steady state with a long half-life compound.

Pharmacokinetic Studies
Studies that can be conducted include evaluation of healthy male and female subjects or special populations.

For whatever your Phase I needs, Lifetree Clinical Research® is ready to help.

Phase II-III Capabilities:

Addiction Liability Capabilities:

Care of patients fighting substance abuse requires sensitivity to the issue and careful monitoring of outcomes.

Lifetree Clinical Research® has participated in several addiction medicine studies that required close monitoring, multiple PK draws, and lengthy in-patient stays. Lifetree Clinical Research® Center continues to grow in it's commitment to researching all areas of addiction medicine.

Our highly trained research team is lead by Dr. Lynn R. Webster, board certified in pain medicine, anesthesia, and certified in addiction medicine. Dr. Webster has co-authored several recent abstracts regarding the Phase I studies that Lifetree Clinical Research® and Lifetree Pain Clinic have conducted.

Clinical Trial Management Services

• Project Management
• Study Design and Protocol Writing
• Site Recruitment and Management
• Participant Recruitment
• Site Monitoring
• Medical Monitoring
• Medical Writing
• Quality Assurance
• Developing Standard Operating Procedures (SOP's) for Clinical Research Sites
• Investigator Meeting Planning
• 48 Hours Turn Around for Regulatory Documents

• On-Site Experienced MD Investigators
• On-Site Research Pharmacist
• On-Site Certified Research Coordinators' many are RNs, LPNs, and MAs
• On-Site Certified Cardiac Sonographers
• On-Site In-Patient Beds
• On-Site Anesthesia Support
• Documented Training Curriculum
• ACLS trained staff including RNs, Paramedics, and MAs.
• On-Site Quality Assurance
• Real Time Quality Control
• Electronic Data Entry
• State of the Art Monitoring Equipment
  • VS
  • Cardiac Telemetry
  • Echocardiography
  • ECG
  • Pulse Oximetry
  • Apnea
• Laboratory
• (2) -70° Freezers
• -40° Freezer
• Centrifuge-Ambient & Refrigerated
• Large Database of Healthy Volunteer Subjects

• Experienced pharma personnel with a track record of successful drug development
• Multiple drug approvals (US and EU)
  • Blockbuster brands in major pharma portfolios
  • Lifecycle management and brand extension products
  • Pediatric approvals
• Multiple INDs in pain and related areas
  • Full IND services:
    • Preclinical compound assessment
    • Evaluation of animal pharmacology
    • Preparation for first in human trials
    • Document preparation
• Broad range of regulatory experience
  • Labeling negotiations
  • drug approvals
  • advisory committees
  • EU approval process
  • Pediatric Rule Compliant program development
• DIRECT experience with current regulatory environment and current review division personnel
• Extensive Development AND Regulatory experience with:
  • ALTERNATIVE FORMULATIONS
  • ALTERNATE ROUTES OF DELIVERY
  • COMBINATION DRUG PRODUCTS
  • ABUSE LIABILITY ISSUES
  • PEDIATRIC ANALGESIC DEVELOPMENT

Lifetree Clinical Research® staff have aided in pioneering the development of new research models 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 is designed to support our knowledge, and the expertise in conducting innovative new model clinical trials.

Dr. Lynn Webster
Dr. Webster is Board Certified in Anesthesia, Pain Medicine and certified in Addiction Medicine. His private practice incorporates more than 2,000 chronic pain patients from a multi-state area. Dr Webster's clinical research experience spans 20 years and Sponsors continually rely on his expertise during the protocol development process. Dr Webster has presented multiple abstracts, lectured at several pain conferences while maintaining a busy private practice of patients with the following chronic pain conditions:

• Smoking cessation
• Addiction medicine
• Neuropathic, nocieceptive pain
• Non-cancer pain
• Headache
• Low back pain
• Osteoarthritis
• Post-herpetic neuralgia
• Sleep disorders

Daniel B. Vine MD:
Dr. Daniel Vine is a board certified neurologist and maintains an active neurological practice in the Salt Lake City area. Dr. Vine has extensive investigative experience in clinical trials for CNS, Alzheimer's, diabetic neuropathy, depression, anxiety, epilepsy, multiple sclerosis, Parkinson's, obesity and insomnia. Dr. Vine is a member of the Association of Clinical Neurophysiology.

Alice A Jackson RN, Chief Operating Officer:
Ms. Jackson is Co-founder of Lifetree Clinical Research® and brings 15 years experience in clinical research to the Lifetree management team. Ms. Jackson has expertise in new site development, clinical research operations, business development, protocol development, and project management across multi disciplined teams. Ms Jackson has developed competency-based training for clinical research coordinators, written and trained multiple teams on industry accepted analgesic pain assessment process. Ms. Jackson has initiated, and trained on the importance and implementation of company SOP's. Ms Jackson aided in the development of the methodology for the post-operative bunionectomy model. Ms. Jackson presented as first author two recent abstracts regarding this new acute post-op pain model. First, at IASP in San Diego, August 2002, and then at the APS meeting in Chicago , March 2003. Ms. Jackson also participated in a presentation of study results for the bunionectomy model to the FDA in March of 2002.

Brad Bath, PhD, Vice President, Operations:
As Vice President of Operations at Lifetree Clinical Research™, Dr Bath oversees the both Clinical Trials Management and Clinical Site Operations departments. He holds a Doctorate Degree in Chemistry and has 15 years of experience in drug delivery/formulation and Phase 1-4 drug development with biologics as well as small molecule. He retains the distinction of first authorship of ten scientific articles published in professional journals as well as one book chapter, and continually focuses on innovative, efficient ways to develop drugs and optimize value to our clients. The depth of Dr. Bath's clinical knowledge, and his talent for applying this understanding to clinical research, supports Lifetree's ongoing commitment to our clients to consult and bring optimal value to their products through innovative protocol design and consultations. His proven expertise in building first-rate Project Management methodologies and managing high-performing global drug development teams is leveraged at Lifetree to deliver robustly-planned, quality-driven clinical projects to our clients.

Collectively, the staff at Lifetree Clinical Research® has more than 20 years combined research experience. Each coordinator is ACRP certified and adhere to all Lifetree company SOP's, ICH, FDA, HIPAA and OSHA Guidelines. Our company training program is competency based with documented records of training for each internal and external training courses completed. Each Lifetree staff member has completed BLS and ACLS certification. Lifetree centralized call center supports the efficiency of research subject recruitment to assure thorough screening and timely scheduling of study visits in one phone call. Once the information is collected, the recruitment staff enter subject data into our company database.

Salt Lake City and the surrounding area is home to more than 1.7 million residents. Salt Lake City is known for it's compliant subject population. The demographics are predominately Caucasian, Hispanic and Native American.

Dental/Maxillofacial Surgery
Dermatology/Plastic Surgery
Endocrinology
Musculoskeletal
Neurology
Psychiatry/Psychology