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Maintaining Control



When it comes to managing clinical research, the need for robust project management is self-explanatory, especially when entrusting the operations to a third-party research organisation. Maintaining strict control over quality, process, resourcing, data management, audit trails, and crossparty communications is essential to the success and credibility of outcomes, the management of costs, and the containment of risk.

However, if you step beyond clinical research, biotechnology and pharmaceutical organisations often become more lax in their expectations of formal project management. If they are seeking help with processes such as pharmacovigilance (PV or regulatory submissions and information management, firms’ chief priorities tend to be buying in particular technical prowess and access to scalable resources, placing all emphasis on the relevant technical expertise and capacity of the teams they are engaging.




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About the author


Anna Lukyanova is Chief Operating Officer of Arriello, a provider of innovative, high-impact market access, regulatory affairs, and PV solutions and services for small to mid-sized biotech and speciality pharma firms. She oversees the company’s PV, regulatory, and project management teams, balancing client satisfaction with developing and nurturing Arriello’s growing team. Anna has worked in the pharma industry for more than 14 years in business development and operations. She gained her customer-centric approach from the hospitality sector, where she received extensive training and experience after graduating from university in the US.
anna.lukyanova@arriello.com
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