Let us be a trusted partner in your clinical development efforts.

Acting as an extension of your internal team, we offer end-to-end consulting and services that provide the flexibility to increase and decrease our services based on the timing and phase of your clinical development.

In all phases of development, we will support your study design and execution with a forward-thinking, proactive mindset to ensure timely and continuous progress.

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Expertise in:

  • In vitro diagnostics (IVDs)
  • Laboratory Developed Tests (LDTs)
  • Therapeutic/CDx Codevelopment
  • Biomarker hypothesis development
  • Assay validation
  • Software as a Medical Device (SaMD)
  • Pharmacodynamic endpoints
  • And more...

Therapeutic areas:

  • Oncology
  • Immuno-oncology
  • Rare diseases
  • Inflammation
  • Infectious disease

Technical Expertise:

  • Next Generation Sequencing (NGC)
  • cell-free DNA (cfDNA)
  • Flow Cytometry
  • miRNA
  • Immunohistochemistry (IHC)
  • Digital image analysis
  • To name a few...

Clinical Study Design

Comprehensive and focused clinical study design consultation whether in the beginning stages of study planning or review of a developed study plan, including identification of regulatory requirements for a given phase of development and planned activities (eg, Risk Determination).

Study Protocol Development

Development of clinical study protocols to support execution of a clinical study, whether as a research/exploratory study, analytical validation study, or clinical trial under regulatory requirements (eg, under IDE or IND).

Clinical Study Reporting

Generation of clinical study reports to support regulatory marketing applications, post-market clinical evaluations, IRB closeout submissions, or finalization of a phase of development (eg, Verification & Validation).

Clinical Trial Monitoring

Dependable and thorough clinical trial monitoring for all or a subset of active clinical trial sites, including site selection, site initiation visits (SIVs), and continuous trial monitoring.

All clinical affairs consulting and services can be combined with medical writing activities.

Ready to find out more?

Contact us today with questions or to discuss your project.

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