Non-commercial
clinical trials

  • Documentation
  • CRO/Monitoring
  • eCRF/Data management
  • Statistics
In Western Europe, about 30% of all clinical trials are implemented in the form of non-commercial clinical studies, which include academic- research projects in medicine or investigator initiated studies conducted by universities, scientific societies, scientific research groups or research institutes. *

Non-Commercial Clinical Trials
- aim and benefits.

  • Development of clinical knowledge and practice as well as quality of medical care for patients and standards` improvement of their treatment.
  • Analysis of the effectiveness of approved medicines in different patient populations or in indications other than the original one.
  • An important factor in progress of knowledge in medical sciences.
  • Access to modern and innovative therapies for patients suffering from rare diseases.
  • Raising the qualifications and position of investigators and young scientists.
Medical Research Agency
You can apply for funding for non-commercial clinical trials at the Medical Research Agency. According to the forecasts of the Minister of Health, MRA will have a pool of PLN 40 million to spend in 2019, next year PLN 500 million, and in 2028 almost a billion.

Sponsorship in non-commercial clinical trials:

  • Healthcare center
  • A university or other investigation institution with the right to confer academic degrees
  • Investigator (so-called 'IIS' study - investigator initiated study
  • Investigators organization / patient organization
  • Natural / legal person or organizational unit without legal personality
All of the above entities must meet one condition - the purpose of their activities may not be to make a profit in the area of clinical trials and the manufacture or marketing of medicinal products.
Comprehensive CRO service.
Stage I - Study preparation.
  • Study design, statistical service (developing hypothesis, selecting a sample size, statistical section in the protocol)
  • Cooperation witk Key Opinion Leaders
  • Preparation and / or consultation of study documentation (e.g. study protocol, protocol summary, observation questionnaire, patient information, informed consent form, communication plan, study monitoring plan, study management plan, data management plan, statistical analysis plan, etc.)
  • Documentation of clinical studies submitted to regulatory agencies in Poland (URPL, bioethics committee)
  • Comprehensive project management
  • Communication managemnet between investigators and investigators centres
  • Randomization - construction of a randomization system, creation of randomization lists, drug distribution management system
  • Integration with laboratories
  • Documentation printout for investigators and patients
  • Stationary and online training, video conferences, teleconferences
Stage II - Study implementation.
  • Site initiation, monitoring and close-out visits (CRO)
  • Monitoring and reporting
  • Study monitor`s supervision
  • Reporting of adverse events
  • Data management (data quality control, database cleaning, user account management, etc.)
  • Reconciliation
  • Statistical analyses - interim analysis, tables, listings
  • Financial management (investigators, study centers etc.)
  • Comprehensive project management, - project meetings
  • Helpdesk (phone, e-mail)
  • Server maintenance and hosting
Stage III - End of study.
  • Payment processing (investigators, study centers etc.)
  • Final statistical analyses - tables, listings
  • Final statistical report
  • Cleaning and closing the database
  • Medical coding (Meddra dictionary)
  • Archiving data and documents
  • Assistance in preparing CSR, scientific publications or articles

Recommendation:

That make us unique.
Authorial system compatible with the FDA guidlines (Title 21 CRF Part 11)
Dedicated Project Manager
Full process digitization
A team of statisticians and data managers with many years of experience in conducting clinical and observational studies
Online contracts signing (positive recommendation of DZP law office)
Professional statistics according FDA and Master Journal List standards
Multi-access with a dedicated range of permissions for anyone interested
Niekomercyjne badania kliniczne
Non-commercial clinical trials
according law regulations.

"If the owner of the data obtained during a clinical trial is a sponsor, university, ... or other scientific institution, (...) a therapeutic agent, ... a researcher, a patient organization, an investigator organization or another natural person ... the clinical trial is a study Clinical non-commercial."

Pharmaceutical law, Article 37a

Zadzwoń do nas Napisz