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Leveraging the EHR to Advance Clinical ResearchConverging the processes and data from EHRs and from the electronic data-capture (EDC) of the clinical research environment could change the paradigm of drug development and safety
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Building bridges to rare disease patientsOrphan drug development and marketing have important distinct requirements for R&D, regulatory and marketing
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The dynamic evolution of multi-sponsor REMSRisk Evaluation & Mitigation Strategy (REMS) programs are evolving, with new complexities for compliance managers
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Automated Contract Management Provides Substantial Benefits to Nektar TherapeuticsCLM Matrix system exploits Microsoft SharePoint platform
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Risky Business: What Life Sciences Need to Know About the US Foreign Corrupt Practices Act Before an AcquisitionNearly 30% of acquiring companies do not evaluate FCPA risks prior to an acquisition
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PRIMES: The six key elements of successful drug/device developmentGuidance for companies starting out on the commercialization path
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Supreme Court: reverse payment settlements subject to antitrust scrutinyWhat are the risks of future 'pay for delay' settlements between branded and generic manufacturers?
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New cold chain solutions meet regulatory, shipper requirementsCold chain packagers balance cost, performance and compliance approaches
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The Business Case for RWEHow drugmakers can better harness real-world evidence to drive their clinical and commercial objectives, while also providing greater clarity for healthcare providers and improved access to therapy for the patients they serve.
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Pharma ups the ante on DTC advertisingDespite the buzz around digital media channels, pharma continues to pour marketing dollars into television
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Managing government pricing programsWhen state and federal governments are involved, prices and reimbursements have both regulatory and financial consequences
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Getting products to market fast with the 3PL Title ModelA contractual arrangement that could save time and money for brand owners
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Evolving Patient Access Programs for Specialty TherapiesWhen a physician prescribes or treats a patient with your specialty drug, the stakes are high for everyone. Patient access is evolving to improve the patient and physician journey with specialty therapies
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Lessons learned on bona fide service fees and fair market value-is there a 'right answer'?Recent regulatory actions and court cases highlight the importance of due diligence in reporting the value of service fees when federal reimbursements are concerned. The financial consequences can be substantial
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Why community oncology mattersOncology is the market for today's pipeline products. Here's why the community setting needs to be preserved as a primary site of care to administer those products
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Machine learning finds purpose in commercial life sciencesMachine learning offers business knowledge based on the data that marketers and sales teams generate
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Data logging is not enough for a modern pharma supply chainIoT takes you from living in the past to shaping the future
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Connecting with physicians—and patients—at the point of careIntegrating pharma communications with electronic health-record systems brings value to patients and providers
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The Rising Importance of Observational ResearchInternational efforts to standardize guidelines for observational research could move the entire field forward
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Change is a constant for sales incentive planningSales Compensation Solutions, a new book from ZS Associates, outlines problems and solutions
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The Five Things We Need to Do to Re-invent Commercial OperationsBy running Commercial Operations like a stand-alone business, executives can sharpen their focus on strategy, tactics and overall performance
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Managing government pricing programsWhen state and federal governments are involved, prices and reimbursements have both regulatory and financial consequences
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The Rising Importance of Observational ResearchInternational efforts to standardize guidelines for observational research could move the entire field forward
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3PL selection as part of product launch processThe importance of partners being flexible and optimizing their processes in today's virtual climate
