ITALY +39 010 4077 182
US +185 720 87660

Statistical solutions

For your clinical trial.
If you need to outsource a part of your clinical trial or drug development project, VALOS is the partner you can count on.
CONTACT US
2007
PHUSE member since 2007
SCDM member since 2014
4
offices in USA, Europe, CIS
15
years of experience
40+
statistical and Clinical SAS® programmers
01
About Us
We deliver better quality and on-time completion of projects, helping you to drive your clinical trial's success.
Our team is made of clinical research professionals, having strong education, wide experience and on-going training of the main industry information (such as 21 CFR Part 11 or GCP), market trends and industry standards such as Clinical Data Interchange Standards Consortium (CDISC).

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21 CFR Part 11
GCP
CDISC
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government of the United States.
Good Clinical Practice (GCP)
CDISC is a standards developing organization (SDO) dealing with medical research data linked with healthcare.
Services
02
what
VALOS' experienced statisticians, skilled SAS® Statistical programmers and Data Management professionals can deliver better quality and on-time completion of projects, helping you to drive your clinical trial's success.
Data
Management
  • Defining of EDC system set-up requirements
  • Development, validation and maintenance of the following systems/components:
    • e-CRF (screens, edit checks, notifications, alerts, clinical trial metrics)
    • ePRO
    • Randomization and Trial Supply Management (RTSM) system
    • eConsent
    • Medical coding
    • Data import/export
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  • Devices (e.g. wearables) configuration, data collection and analysis
  • Systems setup for User Acceptance Testing (UAT)
  • Thesaurus dictionaries coding
  • Collected data validation and review
  • Clinical trial progress metrics reporting and alerts
  • Protocol deviation identification and reporting
  • External vendor data upload and reconciliation
  • Interim analysis/(B)DRM conduct
  • Data lock and transfer
Statistical
Programming
  • Statistical Programming in SAS® and R languages
  • Data analysis, including designing analysis datasets, statistics, interim analysis, customized DSMBs (also posted via secure Web site)
  • Reporting of results, production of analysis summaries: production of Tables Listings Figures (TLF) according to Client's needs
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  • Exploratory analyses for publications, abstracts and marketing
  • Double independent validation
  • CDISC data conversion (SDTM, ADaM)
  • Graphical patient profiles
  • Collaboration on ad hoc analyses, regulatory interactions, applications (IND) and annual safety report, reconciliation of safety data
  • Pharmacokinetics analysis
  • Programming support for Data Cleaning and Discrepancy Management
  • Creation, validation and auditing of clinical database and data warehouse
BioStatistics
  • Statistical consulting: program development plans, statistical evaluation of clinical trial design (analysis strategies, supporting methodologies) according to ICH guidelines and GCP
  • Protocol design and review: Clinical Trials (phase I-IV), Simulation and modeling studies, Dose Response Studies, Group Sequential Designs, Adaptive Designs, Diagnostic Studies
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  • Sample Size calculation
  • Case Report Form (CRF) and eCRF Design and Development
  • Randomization Schedule generation
  • Interim Analysis Planning
  • Statistical Analysis Plan (SAP)
  • Integrated summary for safety and effectiveness (ISS/ISE) according to Sponsor's requirements
  • Collaboration on ad hoc analyses, regulatory interactions, applications (IND) and annual safety
  • Statistical reports (including tables, figures and listings)
  • Statistical Review of Clinical Study Report
  • Publication and abstract support
Real-World Evidence Solutions
To support your launch preparation, reimbursement submission, pricing and Market Access strategies we can build together database analyses for:
  • Incidence/prevalence of the disease
  • Disease epidemiology
  • Patient journey
  • Economic evaluation of the disease
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  • Effectiveness of therapies already in commerce
To support your product once in commerce we can help you to switch from efficacy to effectiveness!
Plan with us your chart review or database study:
  • Comparative Effectiveness Research
  • Compliance, adherence and persistence
  • Outcomes Research and Product Safety
  • Pharmacoepidemiology and Pharmacoeconomics
  • Exploit Valos to show the value of your products to payers and decision makers
Who are we?
03
who
The team is headed by Dr. Dmitri Petratchenko, a pragmatic mathematician who has more than 15 years of experience as Senior Statistical Programmer and Clinical SAS® programmer, PHUSE member since 2007. He stays involved throughout the project, ensuring strong science and consistent quality.
VALOS' experienced statisticians and skilled SAS® Statistical programmers can deliver better quality and on-time completion of projects, helping you to drive your clinical trial's success.
What's new
04
news
Contact Us
05
contacts
Phone / Fax
Address
Email
+390104077182
C.so Italia 15/6 – 17100 Savona, Italy (registered office)

Via Ceccardi 4/31 – 16121 Genova, Italy (head office)
info@valos.it
Hello! My name is Peter and I'd like to answer your questions. Feel free to write me!
+18572087660