Diagnostics

We help companies navigate the exciting landscape of new Diagnostics processes, including the discovery and practical application of new Biomarkers, Precision Medicine, and Bioinformatics. From data analysis to full-scale development, our expert consultants and seasoned team leaders can guide you through Diagnostic research, analysis, compliance, project planning, and implementation.

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Areas of Expertise

Research & Development

We deliver individual subject matter experts, full project teams, and project managers who provide cross-functional core team leadership. They drive stage-gated R&D processes forward and help you improve productivity, expand innovation, and reduce costs.

Quality, Regulatory & Compliance

Our consultants rely on deep industry experience to provide effective regulatory support. We help clients respond to citations and 483 warning letters, orchestrate CAPA workstreams, calibrate acquisitions, and secure compliance.

Clinical Operations

Our SMEs and project teams drive complex clinical studies and unprecedented clinical development. We provide clinical trial physicians, clinical leaders building protocols, study management SMEs, clinical research associates, and more.

Manufacturing & Supply Chain

We provide project leaders with deep management experience and specific SMEs with domain expertise to drive efficiencies, tackle challenges, and realize opportunities across global manufacturing and supply chains.

Corporate & Commercial Operations

We help you prove value and operationalize KOL insights by providing technology implementation, project teams, and therapeutic area SMEs such as medical science liaisons and Phase 4 medical experts.

Biometrics

Our SMEs have the domain expertise to handle complex programming and statistical analysis requirements. We deliver statistical programming, biostatistics, and real-world data analysis solutions that focus on timely, high-quality "fit for purpose" deliverables.

Testimonial

What our clients are saying:

"It is rare when a company and its associates can exemplify so many wonderful values with forethought and respect for those in their employ."

– Software Engineer Consultant

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