Genelife Clinical Research Provides Regulatory, project management, site management and monitoring services related to BABE services. We at Genelife Clinical Research, help our client to chose best CRO as per their regulatory needs. We have a close association with the BA/BE CROs of India, Singapore, Middle East countries. We worked with some of the leading European CROs.
We assure our esteemed clients for protocol compliance and adherence to regulatory & ethical compliance through proper site startup, monitoring and closeout activity. Site startup activity starts with selection of BA/BE CRO as per the clients requirements related to budget and regulatory needs. It ends with the site Initiation.
Site Selection Services:
Expertise Assessment: Genelife Clinical Research assesses potential research sites based on their expertise, track record, and infrastructure. We select sites that align with the specific needs and goals of your study.
Regulatory Compliance: We ensure that selected sites adhere to all relevant regulatory guidelines, including Good Clinical Practice (GCP) standards, ethical considerations, and local regulatory requirements.
Logistics and Resources: We carefully evaluate the availability of facilities, equipment, and resources required for sample collection, analysis, and data management, ensuring seamless study operations.
Site Management Services:
Quality Assurance: Genelife Clinical Research establishes a robust quality assurance and quality control system to monitor site performance, data accuracy, and protocol compliance throughout the study.
Training and Certification: We provide comprehensive training and certification for site personnel to ensure they fully understand and adhere to standardized procedures and protocols.
Monitoring: We perform in-process monitoring of study related activities which is in compliance with protocol and global ethical guidelines. We also ensure error free reporting, proper documentation of study procedure and capture deviation and events. We also perform retrospective monitoring and audit of BA/BE studies.
Data Collection and Management: We implement state-of-the-art data collection and management systems, including electronic data capture (EDC) solutions, to maintain data accuracy and integrity.
Adverse Event Reporting: Genelife Clinical Research develops and enforces clear protocols for the reporting and management of adverse events and safety concerns, prioritizing participant safety.
Project Management Services:
Comprehensive Project Planning: We create detailed project plans that encompass timelines, milestones, budgets, and resource allocation for every phase of study, from site selection to data analysis.
Risk Mitigation: Genelife Clinical Research identifies potential risks and proactively develops mitigation strategies to address any issues that may arise during the course of your research.
Effective Communication: Our team maintains open and transparent communication channels among all stakeholders, including sponsors, regulatory authorities, research sites, and contract research organizations (CROs).
Budget and Timeline Management: We meticulously manage project budgets and timelines, ensuring efficient resource allocation and adherence to project milestones.
Documentation and Reporting: Genelife Clinical Research ensures that all documentation, including study protocols, informed consent forms, and regulatory submissions, is meticulously prepared, accurate, and submitted in a timely manner.
Quality Control: We enforce continuous quality control measures to guarantee that your study is conducted in strict compliance with relevant regulations and standards.
With Genelife Clinical Research, you can trust in our expertise, dedication, and commitment to excellence as we partner with you to ensure the successful execution of your bioavailability and equivalence studies, as well as pre-clinical studies. Our services are designed to accelerate the development of safe and effective pharmaceutical products while maintaining the highest standards of quality and compliance.