Clinquest specializes in providing innovative clinical support to biotechnology, pharmaceutical and early-stage start-up companies requiring product development guidance, Phase I-IV clinical trial implementation, and pharmacovigilance services. Our staff thrives on partnering with customers to share our knowledge in crafting clinical research and development solutions. Clinquest welcomes opportunities to guide and manage novel, high potential development programs. Over the years we have developed many successful long-term customer relationships worldwide, and you can be confident that our team is committed to building that same relationship with you. We will provide the experience you expect, the superior results you require, and the innovation you need for your projects to succeed.

Clinquest provides services that span the full spectrum of drug development. We utilize a unique and flexible model which provides clients with the tools to make well-informed development and planning decisions. We provide international clinical research capabilities with offices in the US and EU. We specialize in small to mid-size clinical trials (up to 2000 subjects) and take pride in our staff’s commitment to personal attention for each client.

• Clinical Trial Design
• Protocol and CRF Development
• Data Safety Monitoring Board Organization and Management
• Data Management Services
• Biostatistics
• Medical Writing
• Phase I Study Management
  • First-in-Man Studies
  • Bioequivalency Studies
  • Bioavailability Studies
  • Pharmacokinetics/Pharmacodynamics Studies
• Later Phase Study Planning and Implementation
  • International Clinical Trials Implementation
  • Investigative Site Selection and Management
  • Clinical Trial Monitoring Services
  • Subject Recruitment Planning
  • Data Safety Monitoring Boards

• Comprehensive Preclinical, CMC, and Clinical Product Development Planning
• Study Feasibility Assessments
• Business Consulting Services
• Project Management
• Preclinical Development Consulting
  • Development Gap Analysis
  • Medicinal and Organic Chemistry
  • Biological and Pharmacological Research
  • Quality Assurance Compliance
• Regulatory Affairs Services
  • Regulatory Submissions Management
    • Orphan Drug Applications
    • IND Submissions
    • Periodic Safety Reports and Annual Reports
    • NDA Submissions
    • European submissions
  • Regulatory Strategy Consulting
  • US Agent Services for Foreign Clients
• Business Consulting Services
  • Strategic Planning of Research and Development Initiatives
  • Due Diligence for Prospective Investments
  • Business Development and Market Research

• cGXP Vendor Assessments and Audits
• Clinical Site Audits
• Clinical Research Associate Assessments
• Document Audits:
  • Tables and Listings Audits
  • Clinical Study Report Audits
• Client Audits (SOP compliance)
• cGCP Training Services
• SOP Customization/Implementation Services
• SOP Training Services

• Medical Affairs Services
  • Chief Medical Officer Services (acting CMO)
  • Clinical Trial Medical Monitoring
    • 1571 Safety Responsibilities
    • Trial Safety Oversight
    • Dose Escalation Authorization
    • Protocol Exemption Review
• Pharmacovigilance (PV) Services
  • Clinical Trial Serious Adverse Event (SAE) Processing
  • SAE Reconciliation
  • IND Safety Letter Generation and Site Submission
  • Postmarketing Drug Safety Surveillance
  • Client PV Database Hosting
  • Remote and Onsite PV Personnel Support
• Medical Information Services
  • Toll free number for receipt and processing of:
    • Product Inquiries
    • Product Complaints
    • Adverse Events
    • Serious Adverse Events
  • Literature reviews and data abstraction

Clinquest Europe bv
Marc Riteco
Rossinistraat 46
5344 AK Oss
The Netherlands
+31 412 405 840
+31 412 649 572 fax
Email: mriteco@clinquest.com

Contact Information

Clinquest, Inc.
Jayne Belanger
1 Cabot Road
Hudson, MA USA
Phone: 978-568-8880
Fax: 978-568-8206
E-mail:

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