Pharmacovigilance Solutions

RxMD delivers drug safety and pharmacovigilance solutions that are unparalleled. Our functionally versatile physician-scientists can tackle a myriad of difficult issues.

 

Post Marketing Surveillance

Sponsor required to change label for a billion dollar drug (to reflect new adverse events) and given one year to present follow up data. RxMD joins Sponsor's core team to review, summarize and categorize adverse events (AEs) from safety database and compare with market research data on natural history of disease being treated. At FDA advisory meeting, team demonstrates that AEs occur with disease irrespective of drug. FDA consents to change label again to reflect that AEs could also be disease related.

 

PSUR Creation

Following EMEA strictures on quality of first PSUR (for drug with sales over billion dollars), Sponsor approaches RxMD few days prior to data lock for second PSUR. RxMD detects several discrepancies in assigning of expectedness, inconsistent coding of terms, and inadequate quality of programmed outputs. RxMD manually generates and QCs tables from Sponsor's outputs to populate approximately 40 tables to finalize PSUR within critical timelines.

 

Label Amendments

RxMD requested to review rare adverse event in client's drug safety database. RxMD identifies possible association and recommends label change. Suggestion meets with stiff resistance from Sponsor. RxMD's assessment supported by Sponsor's internationally renowned experts. Sponsor's internal management team concurs with RxMD. Company Core Data Sheet label updated to reflect association. RxMD awarded preferred vendor for future signal evaluation.

 

Signal Evaluation

Sponsor falls behind on review of internal signals. RxMD reviews 1358 cases for 82 signals and makes recommendations on signals needing further evaluation. RxMD contribution clears backlog of events for review within critical timelines.

 

NDA Safety Review

Three months prior to FDA advisory for NDA, US based Sponsor, anxious about safety data, enlists RxMD to review safety data. Sponsor uploads patient level safety data from clinical trials and safety database onto RxMD's ftp server located in India. RxMD reviews 362 cases, identifies 16 cases of critical significance (missing or incorrect SAEs) and 55 of moderate significance (possibly missing or incorrect SAEs). RxMD collaborates with Sponsor to address issues and drug ultimately meets with FDA approval.

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