BioStatistical Consultation   Vital Systems provides biostatistical consultation for every facet of clinical research including Phase 1 through 4 and pharmacokinetic modeling and analysis. Our statisticians can help you with every component of trial design from concept to execution and final analysis. We use the latest approved software for design and analysis and possess a thorough knowledge of trial components and regulatory requirements. Clients may choose from a range of services including sample size estimation, randomization schemes and codes, statistical analysis plans, modeling and interpretation.

	Data Management   Vital Systems offers a complete range of data planning, management, and interpretation services along with full biostatistical support. We provide a complete array of services from case report form development and data process design to database design, development, and management. Vital Systems owns and operates a secure global communication system that allows real-time data entry, access, and analysis. Our web-based technology allows our clients to view case report forms on line, at their convenience. Data review and clarification is handled electronically and corrections are made rapidly and accurately.

	Quality Assurance   Quality assurance is of foremost concern for any clinical research endeavor. Vital Systems places the utmost emphasis on quality assurance and proactive initiatives to address your concerns. Our standard operating procedures exceed GCP and ICH requirements and our knowledge of compliance allows us to provide thorough analysis of your procedures, if required, to highlight strengths and weaknesses. We offer a complete range of quality assurance services. Our experienced staff can provide site qualification, vendor and site auditing, business systems analysis, data management process auditing, and IT compliance and quality assurance auditing.

	Project Management and Medical Monitoring   Our experienced and competent project managers can assist and or direct any phase of your development program. Acting on your behalf, Vital Systems project managers bring years of experience to bear in driving your program goals. Medical monitors provided by Vital Systems are capable, competent, and experienced in all phases of clinical development. Clients can select from a variety of services including site qualification, study monitoring, and study closeout. All monitoring services are supplemented by thorough reporting procedures to ensure the progress and integrity of your trials.

	Secure Study Portal   Our Secure Study Portal provides a complete suite of organizational and group communication tools that can be accessed Anytime, Anywhere!  These enterprise-class tools allow authorized personnel access to protected data and project information. This technology can facilitate information exchange and increase collaboration. The Secure Study Portal provides 24-hour access to study data as it is inputted from multiple sources. The Secure Study Portal is customized for each client, and the Files area provides for file upload and download into folders secured by limited access through tiered-authenticated user groups. For example, secured PDF files of IND documents, study protocols, CRF scans – even SAS databases and study reports – can be posted for collaboration by authorized user-group members and retained online for historical archiving. The Secure Study Portal is a vital solution to the pressing needs of information management in pharmaceutical research.

	Medical and Scientific Communications   Vital Systems’ staff is versed in all aspects of clinical research and publications writing. We can provide consultation and support for all regulatory writing requirements, from IND application to CTD or NDA filing, including protocol preparation, safety reporting, and clinical report writing. We also provide ongoing support for IND and NDA annual updates and regulatory communications. Vital Systems has provided support for numerous client publication strategies including manuscript, abstract and poster preparation. We can help select and choose your experts and representatives, develop your message, and generate interest in the scientific community for your programs.

	Medical Consultation   Vital Systems has extensive experience in a variety of therapeutic specialties including (but not limited to) cardiology, immunology, men’s and women’s health, and diabetes. Our medical staff can help you navigate the multitude of design and regulatory requirements facing pharmaceutical initiatives. Our services include clinical study management, safety review and surveillance, study design and analysis, medical coding, and publications strategy support.

	Regulatory Affairs   Vital Systems can provide support to develop, initiate, and manage your regulatory processes from pre-clinical strategy through marketed product support. Our knowledgeable medical and regulatory consultants can provide assistance or act as your voice to regulatory agencies for both US domestic and global initiatives.