Sunday, March 28, 2010

The Importance of the Sales Team - The Importance of Quality and Communicated Phase 4 Clinical Research

Key target groups must be involved with drug safety and efficacy throughout the life cycle of the drug once approved by FDA. Key groups are physicians, providers, opinion leaders, sales, buyers and FDA. Sales Team - Although not a target group, the sales force must nonetheless be a priority for any pharma engaging in direct to physician sales. The sales team acts as the spokesperson between the pharma/product and the physicians. Pharma must proactively and continuously keep members of the sales force educated on the benefits (and risks) of the product. The degree of success of the pharma sales team directly influences the revenue, ROI, generated for the pharma and the longevity of the brand in the market.

Sales and marketing groups must be proactively informed with consistent, up to date, quality-controlled, clinical trial data and documentation. Global ongoing Phase 4 clinical trials generate global data and documentation. The data and documentation must be organized and managed by experts who serve as gate-keepers for data and documentation version control. Gate-keepers, who are quality control experts in compliance, quality and regulation, ensure quality review and presentation of accurate and adequate, safety and efficacy data and documentation and must interact with marketeers worldwide. Phase 4 clinical research is of course, worldwide.

Remember, every communication to the physician, the patient, the key groups...abstract, newsletter, data, database, clinical protocol, Phase 4 clinical submission, CSR, CTR, expedited safety report, periodic safety update report, annual report, safety narratives and otherwise must be in compliance with regulatory rigor and FDA, Code of Federal Register (CFR) and must be consistent in data, storyline, presentation, statement, claim, product label, previously submitted clinical submission dossiers and must demonstrate clinical, therapeutic application and statistical significance, worldwide. Monitor the clinical trials, monitor the monitors, monitor the quality of the data, review all source documents, follow good clinical practice. Engage experts.

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