spacer
home > > winter 2020 > maintaining control
PUBLICATIONS


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:
0
     

There are no comments in regards to this article.

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

Turkish Cargo keeps growing in the first quarter of 2019

Maintaining its accomplished operations from Ataturk and Istanbul airports as "Dual Hub", the global brand of Turkish Cargo continued its strong growth momentum during the first quarter of the year despite the shrinkage of the global air cargo sector.
More info >>

White Papers

Backward Thinking

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement