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Clinical Site Support & Equipment Consulting & Design Services Team Related information

QT Investigations

QT investigations are a crucial component of the clinical development program, addressing aspects such as clinical safety concerns, drug studies, and QT prolongation risk assessment. With over 35 years of experience, Biotrial is a trusted partner in providing comprehensive support at every stage of a drug trial, from design and planning to data analysis and reporting.

Whether this means including a QT investigation component within a phase I program, performing a dedicated Thorough QT (TQT) trial, or implementing further measures within various Clinical Pharmacology or phase II-III trials, Biotrial’s Core Lab offers the required expertise.

Biotrial Therapeutic Area Cardiology Scaled

In addition to designing QT elements of a phase I trial or dedicated TQT trials, as a CRO, Biotrial can assist in the specific Concentration-QT analysis.

Cardiac Safety and QT Prolongation:

Ensuring the safety of patients is at the forefront of our cardiac studies. Biotrial’s expertise in cardiac safety assessments, including thorough QT prolongation studies, addresses potential risks associated with drug development. Our focus on regulatory compliance ensures that your trials adhere to the highest standards of safety and ethics.

Biotrial-core-lab-consulting-Qt-Investigation

Consulting & Design Services

Biotrial’s Consulting & Design Services, staffed by experts, can help tailor a QT investigation to your compound’s needs. Whether it requires a specific TQT trial or integrating QT components into other clinical protocols, we offer guidance on the study protocol, data collection, and statistical methods.

We can help you to:

Determine the type of QT investigation that is required (e.g., a dedicated TQT trial or a QT component within another clinical protocol)
Design the study protocol and data collection plan
Select the appropriate statistical methods
Interpret the trial results
Provide advice on the overall development plan for your compound

Clinical Site Support & Equipment

Our Core Lab ensures optimal quality for QT investigations by providing state-of-the-art equipment and continuous staff support. This includes worldwide shipment of ECG devices, site training, and 24/7 global support.

We offer a variety of services to support clinical sites, including:

Worldwide shipment of 12-lead ECG or Holter devices for the collection of digital ECGs
Site training on the use of our equipment and data collection procedures
24/7 support for global site locations
Immediate replacement of any defective material
Continuous monitoring of ECG data quality

ECG Analysis & QT Measurement

Biotrial’s Core Lab has a large pool of cardiologists who are specifically trained in ECG reading using state-of-the-art software. Utilizing advanced software and a pool of trained cardiologists, we offer ECG analysis and QT measurement services. This includes the extraction of 12-lead ECGs, various reading methods, and thorough quality control.

Our services include:

Optimized extraction of 12-lead 10-second ECG from continuous recordings
Various reading methods available (semi-automated, fully manual, fully automated)
Thorough quality control and reduced variability

Data, Stats & Reports

At the heart of Biotrial’s Core Lab services lies a commitment to unparalleled data management, statistical analysis, and reporting – critical components in ensuring the success and compliance of sponsors’ clinical drug trials and studies, particularly those focusing on cardiac safety and QT prolongation. Our team of expert statisticians brings extensive experience to the table, specializing in key areas such as PK/PD analysis, QT/RR relationship exploration, and concentration-QT analysis.

We offer a comprehensive variety of data management services, including:

ECG Database Expertise:

Our data management services include creating and maintaining specific ECG databases tailored to sponsor file specifications. This ensures that your data is organized efficiently, facilitating seamless access and retrieval for your drug studies and clinical trials.

Submission-Ready ECGs:

As part of our commitment to quality and regulatory compliance, we provide individual ECGs in submission-ready format (XML) specifically designed for FDA submission. This meticulous approach simplifies the regulatory process and enhances the efficiency of your clinical trials.

The core of successful drug development lies in effective data management and analysis. Our team specializes in handling clinical data with precision and implementing robust statistical methodologies. Whether it’s exploring pharmacological potential or analyzing safety data, we place a strong emphasis on accuracy and compliance.

Quality Assurance & Regulatory Support

Our team of experts possesses in-depth knowledge of regulatory requirements governing clinical trials. We guide clients through the complex landscape of regulatory compliance, helping them understand and fulfill the necessary obligations for successful drug development.

With a global perspective, Biotrial is well-versed in international regulatory frameworks. We help clients navigate the intricacies of compliance across different regions, facilitating a smooth and globally compliant drug development process.

Cardiologist pool specifically trained to ECG over-reading

Large (adaptable according to the study specificities: ECG number, deadline, …)
Specifically trained
Continuous variability monitoring

Continuous QC Policy

Biotrial adheres to a stringent and comprehensive continuous quality control (CQC) policy to ensure the highest level of data integrity and accuracy throughout the entire ECG project lifecycle. Our CQC policy encompasses various aspects of data quality, including:

Coherence Control: Measurements and diagnoses generated by our cardiologists undergo rigorous coherence checks to ensure consistency and alignment with established medical guidelines and standards
Intra-/Inter-Reader Variability Assessment: We evaluate both intra- and inter-reader variability to assess the consistency and reliability of ECG interpretations among our team of cardiologists. This process helps identify and address potential discrepancies in interpretation, ensuring the highest level of concordance.
Quality Control Measures: We implement a range of quality control measures throughout the ECG project workflow

OUR Team

Project Manager

The Project Manager serves as the main sponsor contact throughout the trial and organizes all aspects of the project at Biotrial. They ensure that the study is conducted following the protocol and regulatory requirements.

Technical Manager

The Technical Manager is responsible for the technical elements of the study, including device selection and setup, user manual development, and central reading manual preparation. They work closely with the sponsor to ensure the study uses the most appropriate methods and technologies.

Readers

Readers are selected from a pool of experts based on their expertise in the specific type of ECG being read. They are responsible for reviewing and interpreting ECGs to identify any potential QT prolongation.

Data Manager

The Data Manager collects endpoints into the agreed-upon database format and transfers this data to the sponsor at agreed-upon time points. They ensure that the data is accurate, complete, and compliant with regulatory requirements.

Related Information

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