home > epc > winter 2020 > maintaining control
European Pharmaceutical Contractor

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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

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.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Signant Health Appoints Ian Jennings as Chief Commercial Officer

PHILADELPHIA, PA – March 4, 2020: Signant Health is proud to announce the appointment of Ian Jennings as Chief Commercial Officer to help support the next phase of Signant Health’s growth as a leading advocate of patient focused technology solutions.
More info >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities


The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>

Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement