In this post, we hear from Pharm-Olam's Chief Operations Officer, John Barry, and how he walked the Pattern of Excellence and described the value of it to a prospective customer. Sponsors are looking for CROs to provide more value and to more clearly differentiate themselves. This in part is why Pharm-Olam established its Pattern of Excellence. Through John's story, you may learn how the Pattern of Excellence could apply to you and your next study, with Pharm-Olam as your CRO partner.
When working on a rare disease program, there are far reaching benefits to conducting a natural history (NH) study. In this article, Pharm-Olam's Dr. Jovana Vlajkovic-Josic was interviewed by Melissa Fassbender from Outsourcing-Pharma.
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Personal data privacy has taken another evolutionary step with the release of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons, the General Data Protection Regulation (GDPR). If you work for an organization that is not based in the EU, you may or may not be aware of the GDPR. The GDPR, came into effect on May 25, 2018.
Pharm-Olam specializes in the conduct of complex global rare disease clinical trials. Because Phase 3 trials are designed to assess the efficacy, effectiveness, as well as safety of a new drug, this is typically a difficult, costly and time-intensive process. The difficulty of Phase 3 trials rachets up even more when it is conducted in a rare disease population.
Your clinical trial has been running for years potentially and now it is time to achieve a database lock that is efficient, quality driven and on time. A critical component to the overall success of any clinical trial is how Clinical Data Management (CDM) manages the trial during its conduct and how it closes it out to achieve database lock.