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Clinical Research Consulting

Our clinical research consulting team is prepared to help your organization accelerate your path from research to market, with careful attention to trial design, planning, placement, conduct, and reporting.

Contact Our Clinical Research Consulting Team

Stay on the cutting edge while ensuring high-quality data, compliance, equity, and overall trial effectiveness.

Meeting timelines, progressing recruitment, and ensuring efficient conduct are all critical trial operations that can easily be slowed down without proper strategies ahead of time. And, navigating these complexities in a regulated environment can add to the challenge. Many trial sites lack the analytics, IT systems, strategic partners, and abilities to recruit diverse populations and insure an inclusive and representative patient base. Clinical trial challenges require a proactive approach to meet them head-on.

Clinical Research Solutions

We provide a comprehensive set of trial execution services designed to enhance clinical trial development and operations.

Data Collection & Hygiene

Clarkston supports the optimization of clinical operations and trial execution processes, including reviewing, auditing, and developing Standard Operating Procedures (SOPs), clinical optimization with workflow mapping, and educational design.

  • SOP and Procedure Development
  • Feasibility Analysis
  • GxP
  • Data Management & Analytics

Partnership Oversight

Our team is prepared to manage outsourced clinical trial services, define project scopes, align on key business requirements, and ensure performance metrics are met.

  • CRO and Third-Party Vendor Selection
  • RFI Development
  • RFP Development

Project Management

Excel in creating effective operations structures and teams to improve business infrastructure, ensuring the right support systems, processes, and training are in place for efficient trial execution.

  • Clinical Integration and Mergers and Acquisitions (M&A)
  • Project Management for R&D
  • Clinical Trial Lifecycle
  • Clinical Trial Recruitment
  • Study and Clinical Trial Planning

Clinical Trial Design

Identify and mitigate factors affecting trial execution, including improving enrollment and site engagement.

  • Equitable Clinical Trials (DEI)
  • Clinical Trial Recruitment
  • Decentralized Clinical Trials (DCTs)
  • Adherence to Drafted Guidance Before it’s Mandatory
  • Value-Add Propositions

Clinical Data Transformation

Reducing the cost of research, reaching a more diverse patient population, promptly monitoring patient safety, and bringing novel data sources into trials have been the primary goals for clinical operations teams moving toward an increasingly digital clinical trial landscape.

  • Trial Master File Management (eTMF)
  • Clinical Trial Management (eCTMS)
  • Laboratory Information Management System (LIMS)
  • Quality Management System (QMS)

Pre-Commercial Clinical Research

Our team works with clients throughout all product lifecycle stages to improve patient health and safety. We approach pre-commercial clients differently. Our understanding of the needs at the site, as well as the sponsor and CRO level, enables clients to successfully set-up and execute clinical trials so that drugs can get to market. We leverage our knowledge of common challenges in managing clinical trials and our expertise in clinical research regulations and guidance to set clients up for success.

Enhance clinical trial performance with effective clinical research strategies.

Clinical research has become an over-complicated process, but we can help! Our proven clinical resources and years of life sciences industry expertise span across various phases of clinical development. We’re prepared to help your organization establish a tailored approach that fits your needs. Contact one of our experts to find out how our clinical research solutions can accelerate your clinical development and operations to market.

Would you like to learn more about our Life Sciences Industry expertise?

Learn More About Clarkston’s Life Sciences Consulting

Clinical Research Experts

Contact Us to Learn More About Our Clinical Research Consulting Services

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Phone: (919) 484-4400

Contact Us to Learn More About Our Clinical Research Consulting Services

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