Early Phase

Pierrel Research offers clinical pharmacology services in three Phase I Units located in Romania. Their experts warrant that studies are carried out safely and effectively in accordance to GCP.

Pierrel Research offers clinical pharmacology services in three Phase I Units located in Romania (Timisoara and Arad). An interdisciplinary team of experts warrants that studies are carried out safely and effectively in accordance to Good Clinical Practice (GCP) requirements for a wide range of research fields.

Pierrel Research provides professionally conducted human Phase I, early Phase II and bioequivalence studies on up to 64 in-patients in parallel. They can test compounds and devices in healthy volunteers, patients, and special populations. Working closely with General Practitioners and Specialists, Pierrel Research have always been able to meet the criteria for subject recruitment and to deliver timely results and high quality data.

Pierrel Research staff is trained in ICH-GCP, basic and advanced life support, and national legislation, regulations and requirements for clinical studies.

Structure and Equipment

Subject Area

• Wards (bedside alarms, video surveillance)
• Dining/recreation room
• Bathrooms

Medical Area

• Consultation rooms (ECG, Stress test, BP Holter, ECG Holter, Ultrasound, Spirometry, etc.)
• Emergency rooms (Emergency trolleys, defibrillator, portable ECG, PEEP ventilator, oxygen supply, etc.)

Biological Sampling Area

• Biological sampling area
• Nursing station
• Laboratory (chemical niche, cooling centrifuges, – 20° / -70° freezers with automatic temperature control and alarm)

All locations are provided with radio-controlled centralized clocks, fire alarms and protection systems, refraction alarms, controlled access and video monitoring, emergency power generators and UPS.

Their Clinical Pharmacology Unit’s subject pool includes a total of about 4,000 male and female volunteers.
Pierrel Research have established a referral network of hospital departments, GPs and specialist consultants, warranting access to patients for conducting Phase I – II studies.

Their primary target trial subject populations include healthy male and female volunteers, postmenopausal women, pediatric patients and patients in the following therapeutic indications:

• cardiovascular (e.g., hypertension, CHF, obliterative- and cerebrovascular pathologies)
• metabolic and endocrinologic disease (e.g., diabetes mellitus, dyslipidemia, hypo/hyperthyroidism and hypopituitarism)
• hepatology (e.g., liver impairment),
• nephrology (e.g., renal insufficiency)
• gastroenterology (e.g., gastro-esophageal reflux disease, peptic ulcer, irritable bowel syndrome, chronic constipation)
• neurology (e.g., dementia)
• pulmonary disease (e.g., COPD, asthma)
• rheumatology (e.g., rheumatoid arthritis)
• oncology

Study Type

• First-In-Human
• Single/Multiple Ascending Dose
• Clinical Pharmacology
• PK/PD
• Cardiac Safety (QTc)
• Safety Tolerability
• Food/Drug Interaction
• Age/Gender
• Bioavailability
• Bioequivalence
• Variety of Dosage Forms
• Vaccines
• Medical Devices

Expertise

• Cumulative experience of 90+ man-years in clinical practice in bedside and/or ambulatory/family medicine patient care; 80+ man-years history in clinical trials; considerable experience in medical writing.
• 120+ trials involving about 4,800 trial subjects: about 40 Phase I studies including 15 ‘First In Man’ projects, 30+ bioequivalence studies, and 10+ Phase II trials.

External quality control measures:

• 14 trial-related inspections by Competent Authorities
• 7+ system audits, including inspections related to accreditation
• 45+ trial-related Sponsor audits

Recruitment Potential

• Our research units are located in 3 different cities, covering around 2 million inhabitants
• Referral network developed with GPs and specialists
• Proximity to emergency facilities
• State-of-the-art emergency and resuscitation equipment
• Large database of healthy volunteers and many diverse patient populations available in-house

Key Advantages

• Fast EC submission and approval
• Study start within 1 week from EC approval ("Fast 2 First")
• Fast recruitment
• High flexibility
• Unparalleled in-house experience across a spectrum of therapeutic specialties
• Vigorous QC process to ensure data integrity
• Timeline-oriented and results-driven