MULTISPECIALITY EARLY PHASE RESEARCH UNIT
SPECIAL COMPETENCY IN CNS, METABOLIC PD MEASURES AND ONCOLOGY
Pivotal’s inpatient phase 1 and 2a unit is a niche provider
for demanding protocol designs and access to patient populations. We
are focused on CNS, metabolic, women’s health and Oncology studies
with special pharmacodynamic capabilities for trials requiring patient
populations, customized procedures and maximum investigator involvement.
SPECIALIZED CAPABILITIES
EXTENSIVE CNS and METABOLIC PD MEASURES
- Adipose Biopsy
- Alzheimer’s and dementia scales
- Computerized cognitive testing
- CFS sampling
- Depression, anxiety measures
- OGTT measurements
- Parkinson’s UPDRS Scale
- Punch biopsy
ACCESS TO PATIENT POPULATIONS
- ADHD, autism
- Alzheimer’s disease
- Anxiety
- Depression
- Diabetes (including diet and exercise control)
- Healthy volunteers
- Insomnia
- Migraines
- Obesity
- Oncology (Advanced Malignancy and Solid Tumors)
- Pain: neuropathic, chronic somatic
- Parkinson’s disease
- Pediatrics
- Restless Legs Syndrome
EARLY PHASE EXPERIENCE
- Biologicals: vaccine, monoclonal antibodies
- Clinical Pharmacology (PK/PD) Phase 1a, 1b
- Drug-drug interaction
- Early efficacy studies (Phase 2a)
- First human dose
- First in disease
- Maximum tolerated dose in patients, healthy normal
- Proof of concept (POC)
WIDE EXPERIENCE
Pivotal Research Centers collectively has successfully completed over
600 clinical studies encompassing all phases in over 45 indications
including multiple phase 1/2a trials. With the addition of Oncology,
Pivotal Research Centers is a well rounded and diverse research facility
with the capability and experience to handle all of your needs.
We have an enviable reputation for excellence and quality in our studies.
Pivotal understands what it takes to make a successfully study and accordingly
employ experienced personnel who know their jobs and can properly and
accurately execute your protocol. All clinical staff is also BLS and
NIH certified to ensure participant safety.
PATIENTS
Phoenix is the 5th most populous metropolitan area in the United States
with over 4.0 million inhabitants and the second most populous county
in the US. It is one of the top retirement destinations in the nation
with 300,000 retirees over the age of 65. There is also a large population
of working age residents. Over 650,000 persons have moved to the Phoenix
area in the 1990s, making it the fastest growing city in the U.S. Pivotal
has proven expertise in recruitment strategies such as advertising and
public relations. We have a searchable database of 20,000 potential
subjects accumulated through advertising.
Pivotal provides rapid study start-up and enrollment, with quality assured
by the Pivotal Quality System and confirmed by multiple sponsor-generated
audits and a clean (no 483) FDA audit. Plus, we have internal processes
to ensure first time data quality.
EXTENSIVE SERVICES
With our ability to utilize a central IRB, we can initiate your protocol
quickly in order to complete the study in a timely fashion.
- CT Scans
- DEXA
- Flash freezing of tissue (liquid nitrogen)
- IV Infusion capability
- Local safety laboratory (off site) with stat results 24/7
- On-site pharmacist
- PET and quantitative MRI
- Polysomnogram (PSG)
- Protocol consultation
- X-Rays
CLINICAL FACILITIES
- 15 beds
- Crash cart and AED equipment
- Minus 80 degree (Centigrade) freezer
- Refrigerated centrifuge
- Oncology Unit
*7-10 chairs
*Chemotherapy room
*Laminar flow hood (chemotherapy prep)
CLINICAL LABORATORY
We can offer both stat safety labs through Sonora Quest Laboratories
and PK development and assay through Kronos Science laboratories. The
Quest labs will turn around safety labs in 4 hours 24/7.
Kronos Science is a fully accredited and certified laboratory, licensed
by the U.S. Department of HHS under the provisions of the Clinical Laboratory
Improvement Amendments of 1988 (CLIA 1988) CLIA # 03D0966454. Kronos
Science is also certified by Johns Hopkins’ Medical Laboratory
Certification Program.
|
Home
Pivotal
Research Centers is a wholly owned subsidiary of Pioneer
Behavioral Health