Clinical Research

Drug Development Planning

Pierrel Research Italy can provide our clients with a team of experts to help guide you through your development planning. In addition to medical advisers, we have regulatory experts who can help you put together development programmes which will satisfy both your commercial needs and the tough requirements of the regulatory authorities.

Phase I trials

Pierrel Research may offer Phase I services by the mean of the three Phase I Units located in Romania (Timisoara and Arad) and Hungary (Budapest). An interdisciplinary team of experts ensure that studies are carried out safely and effectively in accordance to Good Clinical Practice requirements for a wide range of research fields.

Characteristics:

• Capacity of about 50 trial subjects per day
• Continuous safety monitoring (Holter-ECG, Blood Pressure Monitor)
• Backed up by a cooperating hospital emergency care unit
• Indication specific investigational methods (e.g. pH-metry, spirometry, ultrasound, ECG)
• Assured high degree of individual medical care for all volunteers / trial subjects
• Beside healthy volunteers also special population volunteers

Services and Expertise:

• Bioequivalence / Bioavailability Trials
• Pharmacokinetic / Pharmacodynamic Trials
• First-in-man Trials
• Interaction Trials
• Specific volunteer populations: beside healthy volunteers also symptom carrying volunteers
• Respiratory (asthma, COPD)
• Gastrointestinal diseases (GERD, gastric ulcer, H. pylori positive)
• Cardiovascular (CHF, hypertension)
• Hepatic or renal impairment
• Pediatrics population
• Diabetes

Phase II-III trials

The most expensive and time-consuming stage of clinical development demands a partner who can help to speed up the process and control costs whilst ensuring that regulatory requirements are met.

Pierrel Research Italy ensures that your studies are placed in the most advantageous regions for patient recruitment with carefully selected investigators to help maintain quality.

We have experienced Project Managers who will oversee the process from start to finish and anticipate problems before they arise.

We are able to provide the full range of clinical trial services, including:

• Study design & protocol writing
• CRF & patient diary development (paper or web-based)
• Patient information & informed consent writing
• Investigational site identification and coordination
• Ethics committee applications
• Regulatory authority applications
• Investigator meetings
• Trial supplies management
• On-site monitoring
• Project Management
• Query management
• Adverse event handling
• Audits for ICH-GCP compliance
• Data capture and management
• Coding
• Medical review
• Integrated study report writing

Phase IV and PMS studies

At Pierrel Research Italy we appreciate the need for properly thought through late phase studies in order to gain the maximum scientific value whilst meeting the needs of Marketing. We understand that Phase IV and Post Marketing Surveillance studies can be invaluable for furthering the profile of your product and developing the market. We offer the complete package of services for late phase studies as we do for pre-registration trials.

Late phase studies can often be very large, involving many centres, an ideal setting for the use of Hypernet to help manage the trial and reduce costs.

Outcome and non-interventional studies

An increasing requirement for "outcome and non-interventional studies" conducted in the setting of both the General Practice and Referral Hospitals , aimed at collecting viable information, on diseases as well as on new product's cost-effectiveness and QoL, in the normal healthcare environment, is being asked more frequently by health authorities and scientific communities. At Pierrel Research Italy , during the last years , we got quite an extensive experience in designing, conducting and reporting dozens of very large multicentres non-observational studies , involving thousands of GPs and Specialists.

The use of our e-Clinical trial solution (Hypernet) , allowed the collection of high quality data from hundreds of sites, within the planned timelines and at a very competitive costs.