Clinical Operations

Confidence Flows in Everything We Do

Quality is Found in the Details

Catawba Research provides an easy-to-access one-stop shop for Sponsors seeking clinical trial management services.  From start to finish, Catawba Research has it all.  Our team has generated more than 100 clinical research protocols and study designs for trials in Phases I, II and III.  Catawba Research has carried out NDA, ANDA and 505(b)2 clinical trials with Sponsors from all over the world.  We have successfully engaged in numerous clinical trials ensuring our Sponsors meet their timelines and stay on budget. 

Clinical site monitoring is essential to the effective execution of a clinical trial.  At Catawba Research, we have a full-time staff of Clinical Research Associates (CRA) and use contract CRAs, as needed.  We are committed to tailoring our clinical monitoring practices to the needs of Sponsors, so they feel sure their trial has the highest quality data for submission to regulatory entities.

Scientific and Regulatory Affairs

Experience, knowledge, reliability – Catawba Research has it all. In fact, that’s exactly why we hold a robust leadership position in the Scientific and Clinical Regulatory Affairs disciplines. To date, our expert team has generated more than 100 clinical research protocols and clinical study designs for Phase 1, bioequivalence, Phase 2 and Phase 3 clinical programs.

Catawba’s network is rock-solid, as well. Over the years, the company has built relationships with leading authorities in many areas, among them data management, regulatory affairs and biostatistics. Clients completing ANDA, ANDS (Canada), NDA and NDA 505(b)(2) submissions also can count on Catawba for comprehensive regulatory consulting. This regulatory support and oversight provides a strong foundation for a successful clinical program.

Study Management

Catawba Research is dedicated to meticulous, timely Clinical Trial Management – from proposal, through trial, to final deliverable. Here’s why you can trust our process: Our team ensures efficient trial planning by plotting a “map” of a well-defined project course – from smooth launch, through effective navigation and reliable outcomes. To make sure we stay on the right road, we also run progress checks throughout the study’s duration.

Project Management

At Catawba Research, one key tenet drives our process – capable Clinical Project Management lies at the heart of all successful outcomes. To this end, our experienced project managers set study expectations, and then coordinate, guide and lead our expert team. With on-the-mark tracking, clear communication and cross-group collaboration, our clients can be certain their project will move fluidly, from start to final report.

To further ensure a positive, reliable client experience, Catawba implements a three-component clinical project management strategy:

  • Clinical monitoring plan
  • Safety management plan
  • Overall project management plan
This three-pronged approach facilitates a smooth journey to the final deliverables.

Clinical Operations & Monitoring

Because Catawba Research and Clinical Research Associates (CRA) are regionally based, reduced travel time is a huge benefit. Even more important, our proximity to client sites allows us to build relationships across many projects. Catawba also uses a group of dedicated, skilled and experienced contractors, so adding to the CRA pool as needed is never a problem.

As experienced clinical trial monitors, the Catawba team implements detailed Standard Operating Procedures (SOPs) during site visits. To assure reliable outcomes, we design custom Clinical Trial Monitoring Plans for every individual study. These describe visit requirements, visit frequency, report production timelines and other criteria.

Catawba Research’s significant experience with risk-based monitoring enables us to provide our sponsors with a number of options in executing FDA guidances.

Site Management

Successful enrollment for any clinical study starts with effective Clinical Site Management. Catawba Research is dedicated to fostering strong relationships with sites, resulting in spot-on assessments of a trial’s existing and potential challenges. This is critical, because for a study launch to succeed, project feasibility must be determined during the proposal stages.

Clients turn to Catawba Research for some excellent reasons:

  • Our database lists more than 300 U.S. sites with clinical research experience.
  • Catawba Research has developed a core group of centers with deep experience in both clinical trial processes and continuing health management for patients.
  • The clinical research sites we partner with have strong therapeutic expertise in their respective specialities, including dermatology clinical trials, women’s health clinical trials, and ophthalmology clinical trials.
  • These highly qualified centers are committed to enrolling only suitable patients in trials; strictly complying with protocols; and generating high-quality, reliable data.

Data Management, Biostatistics and Medical Writing

Catawba Research has built a formidable data management and biostatistics presence in the clinical research industry. Under the guidance and support of our distinguished Advisory Board, the Data Management Leadership team draws talented scientists from both India and the United States.

Catawba Research’s broad and complex professional network allows us to offer medical writing services via specialty service providers. In addition, our gifted freelancers provide second opinions and edits, as well as assistance with other writing projects.

Quality Assurance

Catawba Research can promise that our deliverables are accurate and complete. To back this pledge, we provide meticulous in-house training on quality standards – in line with Catawba Research LLC’s extensive SOPs – to every member of the team.

We are diligently committed to GCP compliance, and our clients can be confident their deliverables are always sound, accurate – and vetted.

For more information about Catawba Research’s services and capabilities, contact us!

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