Observational studies
and clinical trials

  • 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:
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