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.
offices in USA, Europe, CIS
statistical and Clinical SAS® programmers
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).
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.
- 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)
○ Randomization and Trial Supply Management (RTSM) system
○ Medical coding
○ Data import/export
- 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
- 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
- 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
Who are we?
The team is headed by Dr. Dmitri Petratchenko, a pragmatic mathematician who has more than 20 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.