The ResearchDx philosophy is to provide clear, accurate guidance to the Biopharmaceutical, Biotechnology, Clinical Diagnostics and Clinical Laboratory industries.
Biopharmaceutical and Diagnostics Consulting:
Healthcare / Clinical Laboratory Consulting
ResearchDx can provide complete turnkey Clinical Laboratory startup services, or alternatively, we will work with established companies to seamlessly integrate only the components you need into your current framework. ResearchDx specializes in establishing and maintaining CLIA, Accreditation agency (CAP, JCAHO, COLA), and appropriate State licensure”.
- Turn-key Laboratory Outsourcing
- Technical and Clinical Consultant Services
- Contract Medical/Laboratory Director
- CLIA and Accreditation (CAP, JCAHO, COLA) Submissions
- State Clinical Laboratory licensure
- Clinical Laboratory Pre-Inspection Audit, Interim Inspections, Compliance Reviews
- Post Audit Deficiency Resolution and Plan of Correction
- Accreditation-related SOPs, Policies and Controlled Documents
- Quality Assurance, Process Improvement and Corrective Action Plans
- New Assay Design
- Design and Implementation of Laboratory Automation
- Assay Validation Design and Implementation
- Laboratory Staff Training and Competency
- External QA and QC Data Review
- CPT Coding and Billing Review
- Laboratory Send Out Practice Review
ResearchDx has extensive experience with the validation, clinical implementation of Next-Gen Sequencing technologies in a CLIA approved and CAP accredited environment. Ask us about your options for implementation of Next-Gen sequencing in a Clinical laboratory environment.
Email your inquiries to email@example.com
International CLIA certification
ResearchDx has extensive experience in navigating international companies through the United States Clinical Laboratory Implementation Act (CLIA) international certification process, and College of Pathology (CAP) international accreditation process (where required).
Many pharmaceutical company clinical trials are requiring these internationally recognized standards, and the process is slightly different for international laboratories. To discuss your individual requirements, please email firstname.lastname@example.org, or contact us.
Our team experience includes:
- Assay development, platform evaluation, and validation
- Management of all levels of regulatory compliance, processes, applications, and approvals
- FDA interface: product life-cycle support / management (program design, pre-IDE, periodic updates, IDE, 510(k), PMA, defense, post-approval, etc.)
- Technology evaluation: utility, application, fit-for-purpose, and patentability
- Market and competitor (SWOT) analysis
- Mergers and Acquisitions
- Guarantee clinical lab certification
- Our experienced consultants can also provide ISO 15189 preparation services for US and international labs seeking ISO 15189 certification