The staff of PCR have extensive cross-cutting experience spanning all aspects of clinical research from preclinical through Phases I-IV, pharmacoeconomic, pharmacogenomic and proteomic. This has included pharmaceuticals, biologics, devices, and serologicals/IVD in both therapeutic and diagnostic indications. Our staff possess an in-depth understanding of the clinical research process, gleaned from backgrounds that include biopharmaceutical and device industry, IRBs, CROs, SMOs, clinical informatics development, investigational pharmacy, in both public and private settings including NIH, academic and community-based. Through the thoughtful application of our experience to the conduct of each trial, the PCR staff is able to provide excellence, quality and performance to our clients.
PCR strongly encourages and supports certification of all study coordinators, investigators and the investigative site. All study coordinators are certified in CPR and have achieved or are progressing toward C.R.C. certification.
Staff capabilities include the following: interview and patient reported outcomes
training, scoring and assessments (FF scoring, FACT and quality of life
questionnaires, diary assessments), spirometry, PFTs, inhalation therapy, PK
sampling, electrocardiograms, blood pressure monitoring (certification for Holter
and ambulatory monitoring), pain assessments and evaluations, joint assessments,
X-rays, IV infusion, throat cultures, buccal scrapings,
gram stains, skin debridement (pressure ulcer treatment), wound dressings, dietary
counseling, patient education, laboratory draws and preparation, HAZMAT
training, and shipping and handling of dangerous goods and all types of
laboratory specimens including pharmacogenomic/proteomic.
Medical Director - medical oversight, performance oversight, contracts negotiation and administration
Manager of Clinical Operations - clinical research management, coordinators and resource management and oversight
Quality Assurance Manager - quality assurance compliance program, change control, quality assurance and control
Regulatory Assurance and Compliance - standards and regulatory compliance, IRB communications, FDA communications
Business Development - marketing and business development, customer relations management
Dedicated Recruitment Specialist - recruitment efforts management and coordination, prescreening activities
Laboratory Manager - lab oversight, CAP/CLIA/IATA certification/accreditation
Investigational Pharmacist and Pharmacy Manager - inventory control, dispensing, IVs and compounding where necessary
Clinical Research Coordinators - certified or progressing toward certification
Education and Outreach Director - patient education and underserved populations outreach
Registered nurses - maintain a pool of perdiem nurses for in-patient staffing
Registered dietician - available on a contingency basis
AREAS OF EXPERIENCE
|
|
Acute Myocardial Infarction
Angina
Hypertension
Hyperlipidemia
Chronic Obstructive Pulmonary Disease
Asthma
Acute Sinusitis
Bronchitis (Acute & Chronic)
Community Acquired Pneumonia
Smoking Cessation
Urinary Tract Infection
Cerebrovascular infarct
Type 2 Diabetes
Osteoarthritis
Vaccines
Fibromyalgia
Rheumatoid Arthritis
Back Pain
|
Gastroesophageal Reflux Disease
Irritable Bowel Syndrome
Crohn's Disease
Ulcerative Colitis
Fecal Incontinence
Cerebral aneurysm
Intracerebral hemorrhage
Diabetic retinopathy
Gene therapy
Genetic screening
Pharmacokinetics
Pharmacogenomics/proteomics
Constipation
Hemorrhoids
Colon Cancer
Herpes Labialis
Genital Herpes
Post-op adhesion prophylaxis
Post-op pain |
A sampling of the Sponsors with whom the staff have worked are listed below:
Abbott, Allergan, Astra-Zeneca, Bayer, Bristol-Myers Squibb, Curon, Epeius
Biotechnologies, Centocor, Ethicon, Genetics, Genentech, Genzyme,
GlaxoSmithKline, Immune Response Corp., Medeva, Merck, Novartis,
Otsuka, Pfizer, Procter and Gamble, Pharmacia, Sanofi (Aventis, Synthelabo), Sandoz, Sepracor,
Schering Plough, Searle, Serono, Solvay, Sucampo, Wyeth-Ayerst
A sampling of the CROs with whom the staff have worked is listed below:
Covance, Kendle, MedPace, Ominicare, Paragon Biomedical, Parexel, PharmaResearch, PPD-
Development, PPD-Pharmaco, PRA International, Robarts, Sciman Biomedical Research, Quintiles, RPS, Quintiles, MDS Pharma, BRANY
A sampling of the Central IRBs with whom the staff have worked is listed below:
Aspire, Biomedical Research, Chesapeake Research, Coast IRB, Essex, Goodwyn, IRB, Inc., NEIRB,Quorum Review, Schulman Associates, Western IRB
A sampling of the Central Laboratories with whom the staff have worked is listed below:
Covance, Quintiles, Quest, LabCorp, Kimball Genetics, LabConnect, Mayo Clinical Labs, Clinical Research Labs, Genomics Collaborative, MDS Pharma Services, PPD Central Lab
|
