top of page

Solutions

Customized Solutions To Your Clinical Business Needs

oversight.png

Pre-market Medical
Device Studies

  • Strategic planning

  • Protocol development

  • Ethics & regulatory applications

  • Logistics & operations

  • Study document development

  • Implementation & management

  • Usability testing

Artboard 3.png

Post-market Medical
Device Studies

  • Planning & Implementation

  • Operations

  • Training

  • On-site support

  • Ethics applications

Medical Writing

  • Protocols

  • Literature reviews

  • Clinical Evaluations

  • Clinical Plans and Reports

  • Publications

Therapeutic Areas

  • Cardiovascular

  • Oncology

  • Imaging

  • Ophthalmology

  • Neurology

  • Wound care

  • Orthopaedic

  • more

Device Types

  • Class I-IV

  • Interventional

  • Diagnostic

  • Software as a Medical Device (SaMD)

  • Combination

Areas of Special Interest

  • AI and ML SaMD

  • Streamlined processes

  • Decentralized clinical trials

  • Participant experience

  • Innovative care pathways

Artboard 6.png

Cross-Stakeholder Collaborations

  • Industry

  • Institutions

  • Clinicians & Investigators

  • Research staff

  • Key Opinion Leaders 

  • Research Ethics Board

  • Regulatory

  • Privacy & Security

Clinical Program Development
& Implementation

  • Organizational assessment & implementation plans

  • Procedure development & SOP writing

  • Curriculum development & training plans

  • Onboarding

Mentoring 

  • Good Clinical Practice

  • ISO 141555

  • Study operations

  • Ethics

  • Regulations

  • Customer experience

  • Best practices

  • Career development

Training

  • Audience-tailored study results training

  • Clinical study operations training

  • Clinical study training for non-research staff

  • Mentoring of clinical research staff

  • Customer experience training

bottom of page