Q&A: Validated Cloud Applications, Inc.

RALEIGH, N.C. -- New tools for the life sciences are always welcomed, especially those that accelerate drug product development. One company doing just that is Validated Cloud Application, Inc. (VCA), which participated in this spring's  CED 2016 Life Science Conference. The following is a CarolinaTechNews Q&A with Dr. Peter Schaefer, CEO, to shed more life on this young startup founded in August 2015.

Q: What does your company do?

A: We accelerate drug development processes by providing validated cloud-based solutions, allowing life sciences companies to focus on their core business, rather than dealing with their IT infrastructure and required validation activities. At this point, we have developed a server-based platform which allows users to execute script-based solutions on a server in the cloud. A standard web browser is used to access the platform, set options, control the execution, and download analysis results. Now we are working on solutions that will run on this platform.




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Q: Why was your company founded?

A: We believe that we can do better than the current providers of these types of solutions. Existing commonly used software requires expensive computer system validation by the customer, is inflexible, and often does not meet requirements, such as CDISC (Clinical Data Interchange Standards Consortium) which is required for submissions to the FDA in 2017. We wanted to offer new software tools which take advantage of current technologies, are offered as a Software as a Service (SaaS) model, and which offer flexible licensing and pricing models.

Q: Where is your HQ and how many employees do you have?

A: HQ is in Raleigh, but we are really a virtual company with no office space at the moment and everyone working on VCA issues is at a different location. The two Founders of the company are Peter Schaefer, Ph.D. (CEO) and Dan Gilroy, M.A. (CTO). Peter is a thought leader and industry expert in CDISC-defined standards, and data analysis and reporting tools, actively involved in the CDISC and PhUSE communities. Peter and Dan have advanced degrees in Mathematics/Statistics, Computer Science, Physics, and Engineering, and extensive experience in the life sciences industry.

Q: What are your company’s core products or services?

A: Vicos:  Vicos is VCA’s platform - an extensible, cloud-based execution environment with a web-based user interface to access and control validated script-based solutions and an integrated data and script repository with technical controls for 21 CFR Part 11 compliance.

NCA-Plus:  Pharmacokinetic (PK) analysis is a key method during drug development to investigate what happens to the drug in the body after dose administration. Today, non-compartmental analysis (NCA) is one of the most widely used methods for PK analysis because of its simplicity and its potential for standardizing analyses from study data preparation to reporting. NCA-Plus is VCA’s NCA solution, using R scripts to analyze data and produce output based on the PhUSE/FDA Pharmacokinetics White Paper.

Consulting services, Training, Coaching:  We provide consulting services, training, and coaching on CDISC standards, computer system validation, software development/script development, Quality Management Systems, SOP drafting, and agile development methodologies.

Q: Who are your company’s competitors and what are your differentiators?

A: VCA’s competitors are established companies and home-grown solutions in the pharmacokinetic analysis and reporting space. Our solutions are better because they are validated, compliant with standards, and server/cloud-based in an extensible environment with an integrated repository.

Q: Does your company develop new technologies or re-apply existing technologies to solve a problem?

A: VCA uses and merges existing technologies (cloud-based infrastructure, open source software tools) to provide tools for scientific and statistical computing by life sciences companies.

Q: Who are your customers?

A: Contract Research Organizations (CROs,) biotech/ pharmaceutical companies

Q: What problems does your company solve?

A: The problems with commonly used software for pharmacokinetic (PK) analysis and reporting include:

Rigid pricing and licensing models
Requires expensive computer system validation
Inflexible desktop software typically does not meet changing requirements

Q: What new products or services or services will you be rolling-out in 2016?

A: Initial roll out of our first system / solution is slated for Q2/2016. VCA is currently seeking partners to develop specific script-based solutions, such as for statistical analysis of study data, bioavailability/bioequivalence analysis, creating CDISC test datasets, CDISC dataset validation, and others.

Q: What makes your company relevant to the future of your industry?

A: The step forward in using current/newer technologies (like cloud computing) which are compliant with standards to accelerate drug development processes. Our platform will enable more collaboration and solutions sharing – so, we believe it will also drive some level of standardization and use of best practices across the industry.

Q: Will your company be participating in any upcoming trade shows or other events, or are you being featured in any upcoming industry publications?

A: VCA recently participated in the Council for Entrepreneurial Development (CED) Life Sciences Conference in Raleigh and the PhUSE/FDA Computational Science Symposium in Silver Spring, MD.

Q: Where can people go to find out more information?

A: Visit www.vca-plus.com or contact Peter Schaefer, CEO at pschaefer@vca-plus.com