Our Services

Audit Support

Optimize your clinical audit program with our risk-based approach that meets, or exceeds, regulations.

·        Partner relationship support

·        Vendor management

·        Clinical site oversight

·        Internal process evaluation

Risk Management

We specialize in finding creative solutions for complex problems.

·        Risk assessment tools and support

·        Process mapping

·        Technical writing

·        Focus on patient impact, data integrity, and product quality

Rescue Studies

Change management is more than change control. Let us help you pivot.

·        Change in clinical vendors mid-study

·        Implement protocol amendments

·        Clinical system data migration

You know systems can make work easier, but the up-front time investment can be a burden to a lean team. Allow us to analyze whether a system will help or hurt your bottom line.

·        ERP, CTMS, EDC, IRT, eTMF, database design, metrics and dashboards

·        Create business requirements

·        Review system specifications

·        Design validation plans

·        Execute UAT

Let our inspection experience guide you to the areas where agencies have the most questions.

·        Vendor mapping

·        Storyboarding

·        Document management

·        Chain of custody

Writing procedures is not easy, and your teams have other important tasks to manage.  Companies cannot afford to prioritize day-to-day tasks over training and compliance.  We have tools and templates that can easily plug into your workflow, or be customized for your unique team.

·        Process mapping

·        Technical writing

·        Knowledge management

·        Compliance training

·        Professional development

Only need skilled support for a short period of time? Try our Bridge Plan which provides short-term, targeted expertise to bridge resourcing gaps or handle quick projects.

·        Clinical system development and implementation

·        Project management

·        Vendor mediation, issue investigation

·        Inspection prep