Viitai has a small but elite team of consultants specializing in life science IT. We recognize that small biotech/CRO companies have limited funds and life science IT expertise. We often see them struggling in identifying and implementing the right IT systems that are efficient, aligned with industry standards and compliant with regulatory requirements; time, money, and effort wasted. We specialize in helping small to mid-size life science companies establish efficient IT infrastructure so that they can focus their limited funds and resources on their core business. Our consultants all have more than 15 years of professional IT experience as heads of IT functions helping biotech startups with only several people grow into middle size enterprises with approved products. We can do the same for you!
Scope of services
- Application Selection: We help you identify the right application to best satisfy your organizational or functional needs.
- System Implementation: We have implemented hundreds of systems successfully, such as, CTMS, EDC, EDMS, eTMF, SAS Server, WinNonLin, RIM, Literature Management System, etc.
- Application Development: We have extensive in-house expertise in developing user-friendly applications that are efficient and compliant with relevant regulations. Please check out our applications under Solutions to see if they meet your needs. Once the application is developed, you can host it yourself or we can host it for you with a guaranteed SLA.
- Computerized System Validation (CSV): We apply a risk-based approach to our validation practices. Deliverables we created include Risk Assessment (RA), Validation Plan (VP), User Requirement Specification (URS), Functional Requirement Specification (FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Summary (VS), and Standard Operating Procedure (SOP), etc.
- IT Technical Roadmap: Compliance requirements grow as the organization grows and it approaches the marketing phase. Some growing companies have to change software applications, sometimes multiple times, in order to meet business and regulatory requirements. Each change involves implementation, validation, data migration, training, SOPs, etc. This is a result of lack of vision and poor application selection. A periodically reviewed technical roadmap will allow an organization to stay on the right path and avoid making short-term investments destined to be a long-term disaster.