Clinical Development St. Louis | Clinical Consulting Services

About Us
Our Services
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.

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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.

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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

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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.

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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

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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.

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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

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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

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Address

19 Oak Park Drive

St. Louis, MO 63141

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ABOUT US | OUR SERVICES | EXPERIENCE

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Contact Info.

Phone:

314-220-7067

Email: camden@camdengroup.com

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