CLINICAL STUDIES IN PHASE I in Eastern Europe Bulgaria

Every Phase I clinical pharmacology study you require, you can expect a fully integrated program from study design, start-up to data reporting. Convex CRC is a clinical research center with a built-in phase I unit in which we have the capabilies and expertize to conduct clinical trials in early phases. Convex center for early drug developemnt is focused on the conduct of single-center clinical trials on healthy volunteers and patient populations:

  • Phase I clinical studies
  • Pharmacokinetic and Pharmacodynamic studies (PK/PD)
  • Bioequivalence and Bioavailability studies (BE/BA)
  • Dose Response
  • IV Infusion Studies
  • Age/Gender Studies
  • Drug Interaction Studies
  • Metabolic Balance Studies
  • Patient Population Studies (Healthy, Renal, Hepatic, Diabetic, Post-Menopausal, Testosterone Deficiency, Elderly, Obesity)
  • Safety and Efficacy studies
  • Food Supplements studie
  • Medical devices studies
  • Vaccines studies

Our phase I unit is designed specifically for early-phase clinical studies, following the guidelines of the UK Medicines and Healthcare Products Regulatory Agency and the ICH-GCP. The stationary part of the unit can accommodate 15 subjects for overnight stay. All essential facilities for storing study drugs, maintaining and storing study documentation, managing biological samples and handling emergency situations are available inside the unit. Specimens are seamlessly transferred for analysis to preferred bioanalytical lab or safety lab of your choice. Recruitment of subjects is facilitated significantly by the fact that the Clinical Research Center is strategically situated within a large metropolitan area, with access to population of over 2,5 million people. Our strongly developed network of referring General Practitioners and the availability of proactive recruitment specialists also brings a great benefit to successful recruiting achievments.

 

OUR EXPERIENCE

OUR SERVICES

OUR CAPABILITIES
  • FIH (SAD/MAD)
  • DDI
  • Food effect studies
  • Thorough QT (TQT) / cardiac safety
  • Bioavailability studies
  • Bioequivalence studies
  • Biosimilar product
  • Proof-of-concept trials
  • Pharmacodynamics / biomarkers
  • High-quality design and execution of clinical trials
  • Preparation of clinical protocols, informed consent forms and key study documents
  • Operational oversight by a highly experienced study team
  • 24-hour medical monitoring and physician investigator availability
  • Clinical data verification
  • Administrative and Regulatory Support
  • Electronic data capture
  • Human sample analysis
  • PK-PD analysis
  • Preparation of clinical study report
  • Purpose-built Phase I unit
  • 15 beds/5 infusion chairs
  • Experienced team of 26 physicians and principal investigators
  • Database of >2500 healthy volunteers 
  • RA inspected facility
  • Faster CTA approval timelines
  • Global Pharma/Biotech Sponsor partnership           

 

General Information of phase I clinical trials:

Phase I is usually the first time a new medical intervention is tried in people. Phase I trials may be offered to healthy volunteers or patients with disease that has not responded to standard treatment. The number of patients in a phase I trial is usually small – from 10 to 80 – and unlike later phase trials all patients on a phase I trial will receive the active intervention. Phase I trials are usually of brief duration – several weeks to a few months – and often take place at specialist hospitals. 

Phase I trials are not always ‘first-time-in-human’ trials. ‘Secondary’ phase I trials evaluate new dosing schedules or combination therapies using medical interventions. These phase I trials may also assess drug toxicity or device function in different patient populations, for example children who were not studied before. Some phase I trials are designed to have ‘on/off’ periods where the intervention is actively used in the patient for a period and then not used for a prescribed period to evaluate its effects. This type of trial is called a crossover trial and is applicable only for some types of intervention. 

To minimize the risk to patients, the dose or setting of the intervention being tested starts very low. The first dose is based on laboratory tests and the effects seen in animals. If none of the patients have any side effects the dose/setting is adjusted for the next patients, who will be given a higher dose. The dose/setting will continue to be increased in this way until some people do get side effects. When the side effects become unsafe the dose/setting is not increased any further and the clinical trial team knows what the maximum tolerated dose/setting is. 

Sometimes a phase I trial is offered to a patient as a ‘last hope’ because no other treatment has worked and a doctor has no other standard treatment to offer. It is also natural for patients to want to try anything available and for their doctors to want to offer something else, especially if the patient wants to undergo more treatment.