Services - Kinetiq

Delivering
solutions.

Kinetiq’s comprehensive consulting services provide the ideas you need to transform your organization.

Our team of experienced legal, ethics, medical and regulatory experts know clinical research. At Kinetiq, we pride ourselves on our proven methodology, quality of work and customer service. We look forward to developing a partnership with you.

Regulatory Advice

Kinetiq’s industry experts can provide expert advice to clients around the world on a wide array of issues related to research and clinical trial oversight including:

 

  • Ethics Review Board requirements
  • Institutional preparation for single IRB review
  • Research using mobile technology
  • Social Media
  • Informed Consent
  • eConsent
  • Part 11
  • HIPAA Compliance
  • Conflict of Interest
  • US, Canadian, and global regulatory requirements
  • GCP Compliance
  • Unanticipated problem and noncompliance interpretation and policy implementation
  • Recruitment plans and campaigns
  • Types of research such as device, research involving biospecimens, Phase 1 – 4, minimal risk research, and research involving vulnerable populations

Regulatory Compliance

Kinetiq experts in good clinical practice can help ensure that you understand and navigate the changing regulatory landscape. We provide support and training in:

 

  • HRPP advice, evaluation, and management
  • Accreditation evaluation and support
  • Part 11 compliance assessment
  • Agency inspection readiness
  • Audit readiness
  • Compliance assessment of research sites and ethics review boards

Medical Writing

Let our medical writing specialists help you develop or edit grants proposals, protocols, consent forms, recruitment materials, clinical trial result summaries, and other study documents. We can also assist with a compliance review of your existing grant proposal, research protocol, consent form, and other regulatory submissions.

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