BioStatistics for Clinical Trials
Statistics | eCRF

Compliant with FDA and EMEA

Active studies

Biostatistics for Clinical Trials

Our biostatistics center provides comprehensive solutions in terms of planning, organizing and conducting research, as well as processing data from a variety of different research projects. We have 15 years of experience in cooperation with pharmaceutical and medical industries.
We provide our customers with personalised handling of tasks in the area of biostatistics:

  • Clinical trials, epidemiological studies, bioequivalence trials
  • Observational, educational, PMS studies
  • eCRF (electronic case report forms) for clinical trials
  • medical records
  • CRO
  • Data analysis
  • Research of the medical sector (Poland, CEE)
  • Marketing research, including advertising messages, flyers, packaging, quality of customer service (mystery shopping), customer satisfaction

Our services are employed not only by well known pharmaceutical companies, but also by the best Polish research centers. We have carried out research projects within various fields, including oncology, cardiology and neurology. We’ve processed data that comes from DNA sequencing and analyzed gene expression. In our everyday practice we use the best available bioinformatics tools (Blast, Phred / Phrap, BioConductor). Our team includes specialists in the field of biostatistics, bioinformatics and data management, whose analysis were published in journals of the Master Journal List.

Our high qualifications, scientific background and years of experience in collaborating with clinicians and companies from the pharmaceutical and biotechnology industries guarantee our customers the reliability and accuracy they require. Our research is carried out in accordance to the principles of Evidence Based Medicine (EBM).

01Research Organization

  •  Development of a study protocol
  • Statistical Analysis Plan
  •  Recruitment of participants
  •  Application of the research to the  Bioethics Commitee

01

02

04

03

02Data Management

  • Data collection
  • Randomisation
  • Electronic Case Resport Form eCRF
  • Clinical monitoring / CRO
  • Entering and encrypting the data (including MEdDRA)

 

03 Statistical analysis:

  •  Transient reports and analysis
  •  Dependency / comparison analysis
  •  Discovering the diagnostic rules
  • Survival analyses

We realize our research programs with a proprietary, innovative research platform:


eCRF

ECRF.bizTM software enables conducting of research at the highest level. The system was designed with pharmacy, biomedicine and clinical medicine at mind. The platform guarantees a secure, encrypted access to data, in accordance to guidelines - Title 21 CFR Part 11. The software ensures automatic control of the quality and completeness of data in the course of its registration. It also has enhanced self-reporting mechanisms, thanks to which one may track research progress live. Through the use of sophisticated control mechanisms, audit trail, data query and data backup, along with a statistical module, the data in the system is not only safe, but also ready for even the most complex statistical analysis conducted by our team.

15

years of experience

1000

research

500

publications

Recommendations:

Contact

phone

Phone: (+48) 22 12 28 025
Mobile: (+48) 668 300 664

address

Trade Office - Warsaw
Aleje Jerozolimskie 96
Warszawa 00-807

address

Headquarters - Rybnik
Kowalczyka 17
44-206 Rybnik

email

E-mail: biuro@biostat.com.pl

Zadzwoń do nas Napisz