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How does Parexel support regulatory submissions for new drug approvals? Parexel offers regulatory affairs services to support clients in preparing, submitting, and securing regulatory approvals for new drugs and therapies. Their regulatory experts have deep knowledge of global regulations and guidelines, and work closely with clients to develop and execute successful regulatory strategies.
What is Parexel's track record of success in drug development? Parexel has a proven track record of success in helping clients bring new drugs and therapies to market. They have supported numerous successful drug approvals, including breakthrough therapies and orphan drugs, across a wide range of therapeutic areas. Their expertise, experience, and dedication to quality have made them a trusted partner in drug development.
How does Parexel stay current with industry trends and developments? Parexel invests in ongoing training, professional development, and collaboration with industry partners to stay current with industry trends and developments. They actively participate in industry conferences, regulatory forums, and scientific meetings to exchange knowledge, share best practices, and anticipate future challenges and opportunities in drug development.
What technologies does Parexel use in clinical trials? Parexel leverages a range of innovative technologies in clinical trials, including electronic data capture (EDC), clinical trial management systems (CTMS), risk-based monitoring (RBM), and data analytics tools. These technologies help streamline trial processes, improve data quality, and enhance collaboration among study stakeholders.
What is Parexel's approach to clinical trials? Parexel takes a comprehensive and strategic approach to clinical trials, utilizing their expertise, technology, and global resources to design and execute efficient and successful trials. They focus on innovation, collaboration, and quality to ensure that their clients' trials are conducted in compliance with regulations and meet their timelines and goals.
Who is Parexel and what do they do? Parexel is a global biopharmaceutical services company that helps pharmaceutical and biotech companies accelerate the development of new drugs and therapies. They provide a range of services including clinical trials, regulatory affairs, consulting, and technology solutions to support their clients in bringing new treatments to market.
How long has Parexel been in business? Parexel was founded in 1982, making it a well-established player in the field of biopharmaceutical services. With over 35 years of experience, Parexel has built a strong reputation for delivering high-quality services to their clients.
How does Parexel ensure data quality and integrity in clinical trials? Parexel places a high priority on data quality and integrity in clinical trials, employing rigorous processes, advanced technologies, and experienced professionals to monitor, analyze, and verify trial data. They utilize industry best practices, quality systems, and regulatory guidance to ensure that data is accurate, reliable, and compliant with regulatory requirements.
What geographic regions does Parexel operate in? Parexel operates globally, with offices and operations in North America, Europe, Asia, and Latin America. They have a strong presence in key biopharmaceutical markets and can support clients in conducting trials and obtaining regulatory approvals in multiple regions around the world.
How does Parexel ensure patient safety in clinical trials? Parexel implements robust measures to ensure patient safety in clinical trials, including informed consent processes, safety monitoring procedures, adverse event reporting, and ethical oversight. They adhere to Good Clinical Practice (GCP) guidelines and ethical standards to protect the rights and well-being of trial participants.