services details
Good Clinical Practice
At BioVigate, we are committed to excellence in every aspect of clinical research, and Good Clinical Practice (GCP) is at the heart of everything we do. GCP is not just a regulatory requirement; it’s a commitment to the highest ethical and scientific standards in clinical trials.
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Biovigate has a global reach with staff based across four continents.
The conduct of GCP quality audits is becoming an increasingly challenging process, owing to the complexity of clinical trials and the location of investigator sites.
Although the majority of sponsor organizations reside in Europe, the USA, and Asia, their clinical trial sites are often located in Asia, Africa, South America, the Middle East, and the Far East. Not only are auditors challenged with physically reaching the investigator sites, but they also have to deal with the diverse cultures they encounter.
Biovigate has a global reach with staff based across four continents. Not only does this help with language and cultural barriers, but also the travel time and cost for the conduct of these audits.
Our range of GCP Services Includes;
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INVESTIGATOR SITE AUDITS
▫ Routine Investigator Site Audits (Phase I to IV)
▫ Targeted Investigator Site Audits (Phases I to IV)
▫ For Cause Investigator Site Audits (Phases I to IV) -
SYSTEM AUDITS
▫ System Audits of Sponsor/CRO/ Phase I/BA/BE/ARO Operations -
MOCK INSPECTIONS
▫ Inspection Preparation and Training (Investigator Site/Sponsor/CRO)
▫ Mock Inspections
▫ Inspection Facilitation -
DATA MANAGEMENT
▫ Database Audits
▫ Data Management System Audits -
TRIAL MASTER FILE (TMF)
▫ TMF Audits
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VENDOR AUDITS
▫ Monitoring and Project Management
▫ Data Management, Biostatistics and Medical Writing
▫ Clinical Trial Supply
▫ Interactive Response Technology
▫ Translation Services
▫ Archive Facility
▫ Centralized ECG/Imaging Facilities -
CONSULTANCY SERVICES
▫ SOP Development
▫ QMS Evaluation
▫ Regulatory Intelligence
Experienced Team: Our team consists of highly skilled professionals with extensive experience in clinical research and GCP compliance. From project managers and clinical monitors to regulatory specialists and data managers, our team brings a wealth of expertise to every trial we undertake.
Continuous Monitoring and Quality Assurance: We employ rigorous monitoring and quality assurance processes to ensure that your trial is conducted in full compliance with GCP guidelines and protocol requirements. Our team conducts regular site visits, audits, and data reviews to identify and address any issues or deviations promptly, minimizing the risk of errors and ensuring the integrity of your trial data.
Expertise:
Our team consists of experienced professionals who are well-versed in GCP guidelines and regulations. We provide comprehensive training and support to ensure that your clinical trials adhere to the highest standards of quality and integrity.
Compliance:
We stay up-to-date with the latest regulations and guidelines to ensure compliance with international standards, including those set forth by the International Council for Harmonisation (ICH), the World Health Organization (WHO), and regulatory authorities worldwide.
Quality Assurance:
Quality is our top priority. We have robust quality assurance processes in place to monitor and evaluate every aspect of your clinical trials, from protocol development to data collection and analysis.
Customized Solutions:
We understand that every clinical trial is unique. That’s why we offer customized solutions tailored to meet the specific needs and requirements of your study, whether it’s a small-scale Phase I trial or a large-scale Phase III trial.
Frequently asked question
Biovigate incorporates built-in GCP guidelines and regulatory requirements, ensuring adherence throughout the clinical trial process. It offers customizable templates, checklists, and automated alerts to help researchers stay compliant.
Yes, Biovigate is designed to accommodate various types of clinical trials across different therapeutic areas. Whether it's pharmaceuticals, medical devices, biologics, or diagnostics, Biovigate offers flexibility and scalability to meet diverse research needs.
Biovigate leverages advanced technologies to support remote monitoring and conduct virtual trials, enabling real-time access to study data from any location. It offers remote monitoring functionalities, eConsent capabilities, and telemedicine integration for enhanced flexibility and accessibility.
To get started with Biovigate, you can request a demo or consultation through the official website. Our team will guide you through the implementation process and tailor the platform to suit your specific research requirements.
Email: hello@biovigate.com
