Ensuring Quality

Ensuring Quality

“Quality” in clinical trials is defined as the absence of errors that matter—that is, errors which have a meaningful impact on the safety of trial participants or credibility of the results (and thereby the care of future patients). Once considered primarily in the monitoring process of a clinical trial, we now know that quality considerations must be holistic, woven deeply into the fabric of the research lifecycle from study design all the way through to delivery and dissemination of results. But without the right resources, it can be challenging to know where to start.  

CTTI’s solutions offer straightforward processes for building studies with end-to-end quality and embedding a culture of quality within an organization. Use them to empower teams, foster critical thinking, prevent costly errors, ensure data is fit-for-purpose, and minimize patient burden wherever possible.

Topic Resources

Safety

Antibacterial Drug Development

Increasing bacterial resistance coupled with decreasing research on new antibacterial drugs is creating a crisis that could disproportionately impact our most vulnerable populations, including children and the seriously ill. CTTI...

Ensuring Quality | Recommendations

CTTI Recommendations: Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials

Build quality into the scientific and operational design and conduct of clinical trials. View and download CTTI's recommendations.

Ensuring Quality | Recommendations

CTTI Recommendations: Quality by Design

“Quality” in clinical trials is defined as the absence of errors that matter to decision making—that is, errors which have a meaningful impact on the safety of trial participants or...

Innovative Trials

Optimizing Data Quality and Flexibility in Clinical Trials

CTTI’s project, Optimizing Data Quality and Flexibility in Clinical Trials, aims to enhance patient and site access, improve participant satisfaction, and facilitate the use of real-world data through flexible operational...

Ensuring Quality | Press Releases

New Recommendations to Improve Quality in Clinical Trials

CTTI has issued recommendations and an associated toolkit to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the...

Site Planning | Press Releases

CTTI Offers Path Forward for Using Decentralized Clinical Trials

The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)—trials run through telemedicine and mobile health care providers—today at the DPharm:...

Ensuring Quality | Press Releases

CTTI Addresses Pregnancy Testing Challenges in Clinical Trials with New Recommendations and Online Tool

The Clinical Trials Transformation Initiative (CTTI) today released new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in...

Site Planning | Press Releases

Conducting Multi-Center Trials: New Recommendations and Tool for Research

A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center clinical trials.

Site Planning | Press Releases

CTTI Launches New Online Digital Health Trials Hub

Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.

Recruitment | Press Releases

Clinical Trials Transformation Initiative Releases New Recommendations and Tools for Improving Patient Recruitment in Clinical Trials

CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment that are now available to download. Patient recruitment is a leading challenge in the efficient...

DHT sub topics

Formats

CTTI Project

Stage of Trial