The role of non-commercial clinical trials. CRO in Poland

 

Aims and Benefits of Non-Commercial Clinical Trials.

Non-commercial clinical trials play a vital role in advancing medical knowledge, improving patient care, and enhancing treatment standards. These trials offer several key benefits:

  • Development of Clinical Knowledge: Contributing to the body of clinical knowledge and best practices, thereby improving medical care quality.
  • Effectiveness Analysis: Evaluating the effectiveness of approved medicines in diverse patient populations or for new indications.
  • Scientific Progress: Driving progress in medical sciences through rigorous research and data analysis.
  • Access to Innovative Therapies: Providing patients, especially those with rare diseases, access to cutting-edge and innovative treatments.
  • Professional Development: Enhancing the qualifications and stature of investigators and young scientists in the medical community.

 

Sponsorship in Non-Commercial Clinical Trials

Non-commercial clinical trials are sponsored by various entities committed to research and patient care rather than profit:

  • Healthcare centers
  • Universities or academic institutions with degree-conferring rights
  • Investigators (Investigator-Initiated Studies, IIS)
  • Investigator or patient organizations
  • Individuals or entities without legal personality

All sponsors must ensure their activities in clinical trials do not aim for profit in the area of clinical trials, drug manufacturing, or marketing.

 

Comprehensive CRO Services for Non-Commercial Clinical Trials

BioStat® offers comprehensive Contract Research Organization (CRO) services across all stages of non-commercial clinical trials:

 

Stage I: Study Preparation

  • Study Design and Statistical Services: Developing hypotheses, determining sample sizes, and preparing the statistical sections of protocols.
  • Collaboration with Key Opinion Leaders: Engaging experts to ensure robust study design and implementation.
  • Study Documentation: Preparing and consulting on necessary documents, including study protocols, patient information, consent forms, communication plans, and data management plans.
  • Regulatory Submissions: Submitting clinical study documentation to regulatory bodies in Poland, such as URPL and bioethics committees.
  • Project Management: Providing comprehensive management of all project aspects.
  • Communication Management: Facilitating effective communication between investigators and investigation centers.
  • Randomization: Developing randomization systems, creating randomization lists, and managing drug distribution.
  • Laboratory Integration: Ensuring seamless integration with laboratory services.
  • Training: Offering stationary and online training sessions, video conferences, and teleconferences.

 

Stage II: Study Implementation

  • Site Visits: Conducting site initiation, monitoring, and close-out visits.
  • Monitoring and Reporting: Overseeing study progress and reporting findings.
  • Adverse Event Reporting: Ensuring timely reporting of any adverse events.
  • Data Management: Managing data quality, cleaning databases, and handling user accounts.
  • Statistical Analyses: Performing interim analyses and producing statistical tables and listings.
  • Financial Management: Managing finances for investigators and study centers.
  • Project Meetings: Holding regular meetings to review project progress.
  • Helpdesk Support: Providing support via phone and email.
  • Server Maintenance and Hosting: Ensuring robust and secure data hosting solutions.

 

Stage III: End of Study

  • Payment Processing: Managing payments for investigators and study centers.
  • Final Statistical Analyses: Conducting comprehensive final analyses and generating reports.
  • Database Closure: Cleaning and closing the study database.
  • Medical Coding: Utilizing the MedDRA dictionary for accurate medical coding.
  • Data Archiving: Safely archiving all study data and documents.
  • Publication Assistance: Helping prepare Clinical Study Reports (CSRs), scientific publications, and articles.

 

What Makes BioStat® Unique

BioStat® stands out in the field of non-commercial clinical trials due to several unique features:

  • Proprietary Systems: Our systems are compatible with FDA guidelines (Title 21 CFR Part 11).
  • Dedicated Project Managers: Each project is managed by a dedicated professional.
  • Digitization: We offer fully digitized processes for efficiency and accuracy.
  • Experienced Team: Our team of statisticians and data managers have extensive experience in clinical and observational studies.
  • Online Contracts: Secure online contract signing, endorsed by DZP law office.
  • Professional Standards: Our statistical services meet FDA and Master Journal List standards.
  • Multi-Access Permissions: Providing controlled access tailored to the needs of stakeholders.

By choosing BioStat®, you partner with a team dedicated to excellence in non-commercial clinical trials, ensuring rigorous research and reliable results that advance medical science and patient care.

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Kontakt

(+48) 22 12 28 025
(+48) 668 300 664

Adres

Siedziba
Biostat Ewa Tkocz-Piszczek
ul. Kowalczyka 17
44-206 Rybnik

Adres

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Aleje Jerozolimskie 96
00-807 Warszawa