Resources

CASE STUDIES

Information Technology Assessment of a Clinical Research Organization (CRO)

Biovalorem worked with CRO whose rapid expansion triggered the need to assess their existing Information Technology (IT) structure in terms of software and hardware in order to create a road map on how best to move forward while sustaining existing operations in compliance.

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Suitability Analysis of Health Care IT Standard for NIST

Biovalorem partnered to assist NIST to perform suitability analysis of three specific Health Care IT Standards (Quality Reporting Document Architecture (QRDA), Continuity of Care Document (CCD) and Continuity of Care Records (CCR)).

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Evaluation of Data Sources for FDA’s Blood & Tissue Product Safety Surveillance – Sentinel

Biovalorem supported and partnered to help the FDA by identifying, evaluating and prioritizing the available data sources for blood and tissue products.

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Selecting a Strategic Clinical Research Partner

A global clinical research sponsor was determined to establish long term partnerships with several Clinical Research Organizations (CROs). The sponsor wanted to obtain an unbiased assessment of its identified CRO alternatives and Biovalorem was selected to plan and execute the CRO assessment and provide its recommendations.

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Preparation of Clinical Study Report Template

A global clinical research organization required a standard template for their Clinical Study Report (CSR) to be used during the submission of new drug applications. The client required the template to be prepared in a short period of time, in alignment with the International Conference on Harmonization (ICH) regulations, and helpful for the medical writers to improve their efficiency and quality of the final product.

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Global Alignment of Policies Procedures: Instructions For Mergers and Acquisitions

Today’s ever-changing life science market experiences numerous mergers and acquisitions. Hence, it is not unusual for organizations to realign their internal processes for efficient and effective integration. Biovalorem has performed such integration at the enterprise and departmental level for some of its clients. One case involved the realignment of Policies, Standard Operating Procedures (SOPs) and Work Instructions to meet the process requirements of the newly formed organization and manage the entire integration program.

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