Quality Assurance has become paramount to maintain high standards of quality and compliance in the continuously growing landscape of clinical research. The department of QA in Clinical Research Organization is highly essential to assure that clinical trial and activities go in hand with regulatory standards and are performed ethically. We at Abiogenesis Clinpharm have a dedicated QA team that fulfils all the regulatory requirements, maintain ethical standards and meet the quality.
Clinical Quality Assurance Services
Regulatory Compliance
We comply with Good Clinical Practice (GCP) guidelines, where we safeguard the rights, safety and well being of volunteers by maintaining the data reliability. Our team at Abiogenesis Clinpharm follow all the necessary guidelines as provided by FDA, EMA as well as local regulatory requirements of specific countries where we conduct our own clinical trials.
Management of Quality System
We have an efficient database system for the quality management and the in order to ensure effectiveness in the whole clinical trial process by proper designing and implementing. We conduct internal & external audit to examine the gaps, ensuring adherence to quality compliance and continuous improvements by developing &maintaining SOPs.
Clinical Trial Oversight
We at Abiogenesis Clinpharm adhere to protocols & regulatory requirements to perform quality oversight. We identify potential risks at the earliest & develop strategies to mitigate them &conduct the trials smoothly. An accurate and precise data is provided as a result of effective management of clinical trials so that subcontractors can completely rely on our results thus maintaining integrity of data.
Developed and Trained staff
We at Abiogenesis Clinpharm provide trainings on the latest trends that come up with advancement in technology or clinical trials to meet our pace. Our clinical team is completely familiar with GCP, SOP and regulatory guidelines that we have to follow for the effectiveness of clinical trials.
Audit Services
We at Abiogenesis Clinpharm perform pre audit preparation for your organization so that your organization meet all necessary requirements. The quality assurance audits involves thorough audits of trials sites, processes and documentation where we identify and evaluate compliance issues.
Our experts assists in the development and implementation of CAPA to address audit findings and prevent future complications.
Reporting of Clinical Trials
We at Abiogenesis Clinpharm provide complete information of Clinical trial and follow Good Documentation practices to provide accurate, complete and useful data. AS a CRO, we prepare audit reports, compliance reports and other required documents to support submission to regulatory bodies.
Vendor Identification and Qualification
Abiogenesis Clinpharm performs internal and external audit of third-party vendors and sub-contractors along with meeting all the required and mentioned quality standards and regulatory requirements. Our team regularly checks for quality, safety and compliance with the vendors.
Activities after completion of trials
Our team of medical professionals archives the confidential information and keeps the record of essential information for future reference and compliance with the regulatory. We at Abiogenesis Clinpharm provide comprehensive report of our clinical trials to FDA and EMA.
Sustained progress
Our team believes in constant improvement and for betterment of our services we appreciate the feedbacks that we receive from conducting audits and inspections. Our team consist of experts who stay up-to-date with latest advancements which further helps us to streamline our clinical trial services.
We have experts in QA department who possess ardent passion for excellence which can help you to successfully deal with the complications of clinical trials while complying with all the regulatory guidelines.
At Abiogenesis Clinpharm we perform several activities including preparation of SOPs, vendor identification and qualification, establishment and implementation of quality management system (QMS) and CAPA to ensure the adherence to regulatory requirements. We are at forefront in providing good quality assurance services. We have a dedicated team of individuals who can help you to mitigate regulatory complexities, providing data precision activities, patient well being and maintaining ethical standards throughout the clinical trial process. By collaborating with Abiogenesis Clinpharm you can easily achieve regulatory compliance, ensure the reliability of your research and get success in achieving your clinical trial objectives.