Companies that fail to plan for and address risk management requirements could face delays in making submissions and in getting a regulatory decision on submissions.
Other content in this Stream
Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives
Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by...
COVID19 The Great Decentralized Clinical Trials Accelerator
Learn more from Roz Round, Parexel’s Vice President, Patient Innovation Center about how Decentralized Clinical Trials can help ensure patient safety and enable ongoing trial participation.
2:56Genomics & biomarkers: Answers in the blood
Parexel’s Anita Nelsen, SVP, Translational Medicine and Michelle Hoiseth, Chief Data Officer, Corporate VP speak with Ashley Druckenmiller about caring with her two sons with hemophilia and the benefi
Getting real-world data into clinical research
Learn more about how to address operational challenges that come with harnessing RWD.
Top 10 Myths About Working with the FDA for an Oncology Drug Approval
Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.
On-demand webinar: Value of real-world evidence and synthetic control arms
Learn about the benefits that real-world evidence (RWE) can bring to small & mid-size biotech companies.
The future is now: Decentralized clinical trials during the pandemic and beyond
Enabling patients to participate in clinic trials from home is both important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for COVID-19.
Commercial and regulatory strategy considerations for biotech
In this blog, Parexel regulatory and strategy experts tackle the question of how we can ensure that worthy innovations in the biotech pipeline make it to patients sooner.
Cell and gene therapies: for biotechs, collaboration is key to successful innovation
Learn more about what to look for in the right CRO partner to overcome logistical and operational challenges in cell and gene therapy product development.
Podcast: Opportunities for biotechs in precision medicine, driving value and bringing important new therapies to patients
Parexel precision medicine experts Angela Qu and Arlene Hughes join host Alberto Grignolo to discuss how biotech companies can incorporate precision medicine into their development plans.
2:41Endpoints That Matter
Parexel’s Andreas Reiff, VP, Global TA Head, Inflammation/Immunology talks with Julie Stover, Senior Director, Solution Consulting, also from Parexel, about her journey being diagnosed with Ankylosing
Rare disease and orphan drug designations - What you need to know
Collectively, rare diseases affect over 30 million Americans. The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...
Rescuing Product Approvals from Data Integrity Issues
The pharmaceutical industry is inundated with a plethora of communications about data integrity. Let's look at at one of these situations where applicant holders face these issues successfully.
4:24Parexel Biotech – a patient-centric approach is in our DNA
Hear firsthand from Monica about her personal journey as a clinical trial participant to understand the value of easing patient burden
2:55Parexel Biotech – designed with biotech’s unique way of working in mind
James Anthony, SVP, Global Head Biotech and Graciela Rácaro, SVP, Global Head, Biotech Operations, both from Parexel, discuss how Parexel Biotech has been built to meet customer and patient needs
Improving Drug Development & Patient Access With the Right People, Processes, and Culture
