FDA Restricts Use of Codeine and Tramadol in Children

On April 20, 2017, the Food and Drug Administration (FDA) issued a safety announcement restricting the use of codeine and tramadol medicines in children. Codeine and tramadol are a type of narcotic medicine called an opioid. Codeine is indicated to treat mild to...

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Rx Research Solutions Sponsors 6th Annual CROWN Congress

Rx Research Solutions is proud to sponsor this year's Clinical Research & Operations Worldwide Networking (CROWN) Congress, which will be in  Philadelphia, PA from March 7- 9. We hope you will join us for this three day, three track, four workshops, 30+ Sessions and...

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Notes 2 Fix your Notes 2 File

by Laurie Meehan & Lauren Kelley Q: If Notes to File can be regulatory red flags, should you quit using them? A: No, and here’s why… Regulatory inspections are often conducted long after the conclusion of the study. When an FDA investigator asks you a question about...

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When GCP & GMP Meet

by Laurie Meehan & Rosanne Sylvia-Heeter Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be...

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Site Selection: Don’t Forget About the Study Drug

by Laurie Meehan & Lauren Kelley As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol,...

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Research Pharmacists: Supporting Clinical Trials

Pharmacists are key members of the healthcare profession, and as medication experts their contribution to the landscape of patient care has expanded significantly over the years. The role of pharmacists has long moved beyond evaluation of medication orders and...

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