camdengroup.com

External link opens in new tab or window314-220-7067

camden@camdengroup.com

Menu
  • Link Icon Link Icon Link Icon About Us
    • External link opens in new tab or window Link Icon Link Icon Link Icon Our Services
      • External link opens in new tab or window Link Icon Link Icon Link Icon Experience

        Smart Advice. Exacting standards.
        Meticulous Execution.

        Exceptional Results.

        The Camden Group, LLC operates its consulting, development, implementation, and on-site clinical services as extensions of the client’s project team. We work with R&D teams of all sizes and capacities, complementing available staff to expedite achievement of program objectives. We have experience in working both on-site and remotely with large pharmaceutical and small biotech companies, and can thus offer our clients complete flexibility in work style according to their individual needs and available resources.
         
        The Camden Group, LCC is delighted to work with all clients, those who require simple review of a single study document for regulatory compliance, as well as those who require management of an entire clinical program. We offer each client unparalleled professionalism and commitment to quality.

        Column

        Consulting Services

        The Camden Group, LLC provides a broad range of clinical consulting services to clients. Our extensive experience and success in both basic and clinical research, and proven track record in advancing drug candidates from intriguing laboratory findings to pre-clinical readiness, IND filing, and through clinical development give us the unique ability to “see the whole picture” and guide our clients through the entire clinical development process, foreseeing and avoiding potential pitfalls. At every step, we work closely with each of our clients to fully understand the client's objectives and ensure all needs are met.

        Column

        The Camden Group’s Clinical Consulting Services Include:

          • Design of Clinical Development Programs
          • Preparation of Clinical Development Plans for Targeted Indications
          • Design of Phase I – IV Studies
          • Medical Writing

          • Clinical Protocol Synopses
          • Full Clinical Study Protocols Phase I through Phase IV
          • Integrated Clinical Study Reports
          • Pre-IND, IND, NDA/BLA (including ISS and ISE)
          • FDA White Papers
          • FDA Advisory Committee Briefing Documents
          • Global Submission Dossiers


          Column

          Development Services

          The Camden Group, LLC provides clinical development services to fit a broad range of clinical needs. Our experience working with multiple divisions of the FDA through all phases of drug development assures our clients of regulatory insight and compliance. We work flexibly with each client and are equally comfortable and experienced working as an extension of the client’s project team, or independently, to provide deliverables tailored to the individual needs of our clients. We pride ourselves on our commitment to excellence and to exacting professional standards.

          Column

          The Camden Group’s Clinical Development Services Include:

          • Design of Clinical Development Programs
          • Preparation of Clinical Development Plans for Targeted Indications
          • Design of Phase I – IV Studies
          • Preparation of Clinical Protocol Synopses for Internal Client Discussion

          • Preparation of Clinical Protocol Synopses for Vendor Selection and Funding Exploration
          • Preparation of Full Clinical Study Protocols Phase I Through Phase IV
          • Preparation of Pre-IND, IND, NDA/BLA (Including ISS and ISE), and Other Regulatory Submissions

          https://0201.nccdn.net/1_2/000/000/08c/68f/New-Puzzle-Piece-457x640.jpg
          https://0201.nccdn.net/1_2/000/000/162/4fb/New-Video-Conference-640x418.jpg
          https://0201.nccdn.net/1_2/000/000/0b8/2ac/50New-Gears-214x300.jpg
          0
          Column
          Column
          Column

          Implementation Services

          The Camden Group, LLC provides a number of clinical implementation services to our clients that afford our clients peace of mind that their clinical programs are being managed by experienced professionals with attention to detail and demand for quality. We offer clinical project management and medical monitoring for individual studies and entire portfolios. We work closely with members of the client’s project team and/or with external vendors to ensure no detail of content or timing falls through the cracks, and to deliver the highest possible quality results. We pride ourselves on our commitment to excellence and to exacting standards.

          Column

          The Camden Group’s Clinical Implementation Services Include:

          • Clinical Project Management
          • Study Placement and Study Start-Up Activities
          • Preparation of Site-Specific Documents
          • Medical Monitoring, Including Management and Reporting of Serious Adverse Events
          • Data Management Oversight With Ongoing Data Quality Audit and Query Generation
          • Preparation of Case Report Forms, and Other Program- and Study-Related Documents
          • Clinical and Medical Staffing Long-Term or During Transitional Periods

          Business People In Meeting

          On-Site Clinical Services

          The Camden Group, LLC provides clinical development and implementation services on-site to clients as needs arise. We provide short-term and long-term on-site help to the pharmaceutical and biotech industries to fill staffing shortages and gaps in internal expertise, and during periods of strategic transition. Clients have generally found that 1-2 days per week on-site combined with additional work from our St. Louis-based offices most often meet their needs.

          The Camden Group, LLC

          Column

          Address

          19 Oak Park Drive
          St. Louis, MO 63141

          Site Map

          ABOUT US | OUR SERVICES | EXPERIENCE

          Column

          Contact Info.

          Phone: External link opens in new tab or window314-220-7067
          Email: camden@camdengroup.com

          Column

          Contact Us

          Invalid Form properties detected


          close lightbox