SERVICES

We deliver outstanding clinical data quality.

Clinical Data Management

  • Paper and EDC trials

  • CRF development

  • Data Management Plan

  • Database design, setup and data warehousing of clinical trial project

  • Data migration, mapping and imports

  • Programming of edit checks and data cleaning

  • MEDDRA and WHO data coding

  • IWRS and customized randomization

  • Mapping to CDISC standards compliance

  • Compliance with FDA’s (21) CFR Part 11

Biostatistics

  • Statistical analysis plan

  • Sample size and power calculation

  • Randomization

  • Interim reports

  • Statistical methods, shells, patient profiles, data tables, listing and figures

  • SAS® programming

  • Integrated clinical study report

  • Datasets and analysis database in various formats

  • CDISC standards compliance

  • Regulatory Submission Packages

OUR TEAM

BioDome Clinical gathers clinical research industry professionals with more than 10 years experience in Biostatistics and Clinical Data Management. Diversified by knowledge, unified by experience.

Denislav Ganchev

Principle Clinical Data Manager

Positive, self-driven, goal oriented person with vast experience in Clinical Data Management and IT solutions in the area of Clinical Research. Strong skills in process set up, creation of tools and people management.

Leroy Jide Ovbude

Principle Biostatistician & SAS Programmer

Experienced Biostatistician with a demonstrated history of working in the pharmaceuticals industry. Skilled inClinical Research, SAS programming and CDISC Standards.

Matt Davies

Senior Statistical Programming Consultant

Twelve and a half years of clinical research experience in clinical programming and clinical data management. Eleven years SAS programming experience having worked on various phase I – IV.

Fadi Hussein

Fadi Hussein

Principle Clinical Data Manager

Experienced Principal Clinical Data Manager and CDISC Data Integration Specialist with over 10 years in clinical research, of which 9 years of experience in clinical data management from protocol review to study close out in a number of therapeutic areas.

EXPERIENCE

Diversified multinational team of professionals with in depth experience in Clinical Data Management and BioStatistics gathered in one Company. We are motivated to perform at our best with every project no matter of the scale. Our main aim is to deliver professional services with outstanding quality and speed. Two mutually exclusive definitions, but we believe that our result driven nature combined with expertise have the potential to execute every single project in that manner.

Clinical Phases

We have a track record of projects completed and spread through all clinical trial phases.

Therapeutic areas

Our experience is positioned in more than 40 different therapeutic areas.

Clients

During our path as professional we delivered successfully projects which includes Top 5 of Big Pharma Companies.

Compliance

Our experience include providing regulatory compliant deliveries. This targets regulatory agency requirements to industry wide applied standards.

CONTACT

Address

  • 17 Henrik Ibsen Str.,
    Hladilnika, 1407 Sofia
    Bulgaria
  • info@bdclinical.com
  • +(359) 88 8656 952

© 2017 BioDome Clinical Ltd., All Rights Reserved.