VALOS
Optimizing Clinical Trials with Data Solutions

Clinical researchers at pharmaceutical companies sift through vast amounts of data every day. The sheer volume of scientific data generated in the life sciences industry requires a well-laid-out data management strategy for easy access and management. An ideal solution should be loaded with features that help facilitate trials while managing data, alleviating complexities in designing and executing trials, and ensuring the accuracy and integrity of data.

Enter VALOS, a leading mid-sized, specialized international CRO delivering high-quality data services that help drive clinical trial success. Home to a team of experienced statisticians, skilled SAS statistical programmers, and data management experts, VALOS offers specialized expertise in statistics, statistical programming, data management, and real-world evidence solutions. Its services are designed to help life sciences companies increase efficiency in managing clinical trials on time and on budget, with the latest technologies and resources at their disposal.

VALOS’ statistics service involves the use of advanced mathematical and statistical techniques to analyze clinical trial data for identifying trends, evaluating treatment effectiveness, and assessing product safety. It offers best-in-class statistical programming services that use specialized programming languages to create programs for analyzing data. This helps identify data patterns and create models and algorithms to predict outcomes. VALOS ensures that all data is collected, stored, and analyzed securely and efficiently through its data management services.

“Our excellence in the clinical trial space traces its roots back to our team, which has over 20 years of experience in a range of professional services and across multiple therapeutic areas,” says Dr. Dmitri Petratchenko, Managing Director at VALOS.

Bringing this experience to bear, VALOS understands the issues facing clients when carrying out a clinical trial and develops specialized services with the right technologies to mitigate them. For example, one of the many challenges facing sponsors is preparing their clinical trial data for submission to the FDA. As an expert in electronic submissions, CDISC standards, and CDISC data conversion, VALOS helps meet industry standards and achieve optimal quality in clinical trials. VALOS also supports leading companies in data integration, security, and governance.

The company recently partnered with a leading pharmaceutical company that was struggling to complete a study due to statistician unavailability.

VALOS understood their needs, assigned a statistician, and quickly trained the professional on Sponsor SOPs to be compliant to manage the study. The statistician joined the team six months before the database lock and started working as a member with the support of other statisticians for methodological challenges. It supported their programmers to create efficacy outputs, addressed comments received from the sponsor study team on dry-run outputs, and amended the SAP to support drafting the CSR. The client was able to successfully complete the study with VALOS professionals who helped them deliver all outputs to the team on time, send the CSR to the FDA, and complete the Health Authority Inspection.

Furthermore, VALOS ensures that its clients have effective communication among stakeholders, as it understands that seamless communication is crucial for the successful execution of a clinical trial. By offering responsiveness and undivided attention, VALOS helps its clients to consistently meet their milestones whilst ensuring quality of the results and efficiently responding to changes in requirements.

“At VALOS, we promote a culture of continuous improvement. Our clinical research professionals have strong educational background and wide experience, which are continually enhanced by ongoing training qualifications. Our team is passionate about what we do and believes that can make a positive difference to people’s lives, is driven by ‘Gold Standard’ and core values that focus on flexibility, reliability and delivery excellent results,” says Mikhaela Miliotti, Head of Business Development at VALOS.

With such a comprehensive line of capabilities, VALOS has helped numerous clients successfully execute clinical trials. Today, it offers highly skilled resources to one of the world’s leading pharmaceutical companies, and its programmers operate on a functional service provider model, resulting in enhanced quality and simplified processes. VALOS is a preferred partner for one of Europe’s most renowned biopharmaceutical companies, which uses its statistical programming to receive clinical study reports as submissions-ready deliverables.

VALOS also serves as a trusted service provider for a major software company in California, helping them in bid defence and successful submissions to the FDA. Continuing its winning streak, VALOS also builds long-lasting partnerships with a U.S.-based global medical device company. These partnerships stand as a testament to its ability to provide expertise in all biostatistics, data management and other aspects of the project, work with passion, communicate with transparency, and deliver results with agility and efficiency. Committed to providing the best experience to its clients, team VALOS offers more flexibility for service customization. Its services suite is uniquely tailored to clients’ varying needs and expectations, regardless of their size.

With the right combination of proven expertise in regulatory requirements, global reach and access to resources, and cost-effective and flexible solutions, VALOS carves out a unique niche in the clinical trials space. It serves as a go-to partner that handholds clients through the operational nuances.