Clinical trials
and observational studies

  • CRO/Monitoring
  • eCRF/Data management
  • Documentation
  • Statistics
Our service.
We provide comprehensive CRO services. We manage clinical and observational study projects. We support our clients at every stage of their work.
Stage I - Study preparation.
  • Study design, statistical service (developing hypothesis, selecting a sample size, statistical section in the protocol)
  • Cooperation with external experts and 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)
  • Negotiating and contracting investigators centers and investigators (one/multi-party agreements)
  • eCRF system, start pages, database, validation, instructions
  • Electronic case report form for patients
Zakres usług
  • 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
  • Project management
Stage II - Study implementation.
  • Site initiation, monitoring and close-out visits (CRO)
  • Project meetings
  • Reporting and monitoring
  • Study monitor`s supervision
  • Adverse events reporting management
  • Data management (data quality control, database cleaning, user account management, etc.)
  • Reconciliation
  • Statistical analyses - interim analysis, tables, listings
  • Financial management (investigators, study centers etc.)
  • Project management
  • Helpdesk (phone, e-mail)
  • Server maintenance and hosting
Zakończenie badania
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 (according to the Meddra dictionary)
  • Archiving data and documents
  • Assistance in preparing CSR, scientific publications or articles
That make us unique.
eCRF.bizTM Authorial system compatible with the FDA guidlines (Title 21 CRF Part 11)
Access to the conditions and monitoring the stages of particular research being conducted for all people concerned – Sponsor, CRO and the User
Professional statistics according FDA and Master Journal List standards
Process digitisation and smooth integration of database: eCRF, eTMF-eISF and CTMS
Online contracts signing (positive recommendation of DZP law office)
Other eCRF system functions.
Recommendations:

Frequently asked questions.

What kind of trials do you conduct?
In Biostat® we conduct clinical trials in all therapeutic areas, such as commercial and non-commercial clinical trials (phases 1-4), observational studies (prospective and retrospective non-interventional studies), and market studies.
We also conduct a variety of research such as: a post-marketing surveillance (PMS), Real-World Evidence (RWE), medical registries, Post Authorization Safety Study (PASS), Post Authorization Efficacy Study (PAES) and RX to OTC switch studies.
What does your clinical / observational study service include?
We offer comprehensive services in the area of clinical and observational trials. We are responsible for statistical surveys, eCRF  preparation and data management, preparation of project documentation, monitoring, obtaining approval from Ethics Committee and Regulatory Authority (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products), contracting services for centers and researchers, project management, training etc.
Can you create Electronic Case Report Forms (eCRF) for research?
We offer a unique for the market multi-module electronic data capture (EDC) system - called eCRF.biz™, created in accordance with the FDA guidelines, each time configured for a specific study. You do not need to acquire a separate license to use our software.
Our fundamental functions include: audit trail, data queries, randomisation, drug management, dynamic reports and statistics, adverse event reports, notifications/alerts, online contracts signing and comments module. As you can see our software is useful and attractive to professionals. Furthermore, we provide acceptance testing, full validation (including documentation validation) and data management services.
Do you provide statistical support for the trial?

Yes, we provide comprehensive support in statistics. Its scope includes research design, i.e. sample size calculation, justification, statistical input at the protocol and Statistical Analysis Plan. At the research stage, we are responsible for database construction, transitional analyses, statistical analyses, statistical reports, support in the creation of CSR, publications and articles, and big data analyses. We perform statistical analysis in accordance with the requirements of ISI Master Journal List, known in Poland as Philadelphia List.

Can you prepare a randomisation system?

Yes, we can prepare a randomisation system (Interactive Web Response System, IWRS) for a clinical trial in a form of a separate system or a module integrated with the eCRF system. Furthermore, we are responsible for the preparation and implementation of the randomisation list. The IWRS system complies with the FDA 21 CFR Part 11 standard and enables the randomisation of patients according to the established algorithm and the management of key aspects of clinical trials such as registration, randomisation, dosing, drug dispensing, clinical procurement, drug inventory management, unblinding, etc.

Do you conduct research in paper and electronic form?

Yes. We conduct research in both paper and electronic versions. The vast majority (approx. 97%) are studies conducted in electronic form based on the proprietary eCRF.biz system (an integrated research platform that completely eliminates paper clinical observation questionnaires and allows us to comprehensively manage the entire research project). Electronic CRF (eCRF) enables much faster acquisition of results, and therefore immediate data analysis at every stage of the study. Nevertheless, we have all the resources that also allow us to organize a paper survey.

In which therapeutic areas do you have experience?

We have the resources and knowledge to conduct research in any field. We have the greatest experience in therapeutic areas such as oncology, gastroenterology, transplantology, cardiology, neurology, allergology, psychiatry, neonatology, diabetology, pulmonology, immunology, andrology, proctology, dermatology, ophthalmology, rheumatology, virology and hematology.

Are you providing contracting services for centers and researchers?

Yes. Biostat® provides contracting services for centers and investigators in clinical and observational studies. We negotiate bilateral, tripartite and quadrilateral agreements. We conclude tripartite and quadrilateral contracts in traditional paper form. In the case of bilateral contracts, we use the eCRF.biz ™ system function to conclude contracts online, which eliminates the need to print, scan and send documents via courier. We are also responsible for the financial and accounting settlement process.

Zadzwoń do nas Napisz