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Coordination, Collaboration And Communication: Seamless Teamwork On H1n1 Vaccine Program Results In Multinational Studies With Zero Audit Findings

Challenge

In response to an immediate public health need, a leading pharmaceutical company hired PharmaNet/i3 to help complete a study on the efficacy of a new vaccine developed to protect people from the pandemic H1N1 virus. The client planned to present the results of the study –the first of its kind – to Costa Rican and Argentine regulatory authorities, but language barriers and frequent changes to the trial’s parameters proved daunting. In addition, the client faced challenges as the trial – constrained by tight timelines and already large in scale with approximately 800 patients – evolved from a three to an eight-part study. With new patients registering quickly and those already participating recording weekly visits, the trial became increasingly complex to manage as it progressed.

Solution

To help the client overcome the challenges associated with the H1N1 trial, PharmaNet/i3 provided the expertise, resources, communication skills and flexibility needed to successfully manage the many adjustments regulatory bodies made to the trial, as well as the resulting modifications to the study’s size and scope. At each trial site, PharmaNet/i3 deployed between seven to 14 monitors. Carefully selected to include Spanish-speaking personnel, these monitors worked seven days a week and an average of 12 hours each day. PharmaNet/i3’s team leaders helped the on-site monitors foster a collaborative working relationship with the client and all the other parties involved in the trial. At weekly staff meetings, the PharmaNet/i3 team tracked the project’s progress, highlighted additional needs, celebrated milestones and shared vital information to help educate personnel on the H1N1 vaccine program and its importance to public health.

Outcome

PharmaNet/i3’s partnership with its pharmaceutical client yielded decidedly positive results, both tangible and intangible, but all equally vital to the H1N1 vaccine program’s multinational success. Despite complications created by a tight timeline, linguistic hurdles and the trial’s expanding scope, PharmaNet/i3 proved to be a valuable and trustworthy partner. It helped its client meet all data deliverables and regulatory obligations for this large, aggressive study, which authorities reported zero audit findings for when investigating the trial. In part, these impressive results can be attributed to PharmaNet/i3’s work ethic, attentiveness to teambuilding and sound communication practices. They fostered a culture that empowered all trial staff members to invest in the program and work thoughtfully and tirelessly to achieve its goals.

About PharmaNet/i3

PharmaNet/i3, the inVentiv Health clinical segment, is recognized as a leading provider of global product development services to pharmaceutical, biotechnology, generic drug, and medical device companies, including therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality product development programs of all sizes around the world, PharmaNet/i3 works for you. For more information, visit http://www.PharmaNet-i3.com.

About inVentiv Health

inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv’s client roster includes more than 550 pharmaceutical, biotech and life sciences companies. With 13,000 employees in 40 countries, inVentiv rapidly transforms promising ideas into commercial reality. inVentiv Health Inc. is privately owned by inVentiv Group Holdings Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit http://www.inventivhealth.com.

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