010 40 77 182 info@valos.it

Services

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)

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.

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;
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;
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;
• 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.

Statistical solutions for your clinical trial

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