May 2005
ACDM Senior CDM Forum, 4th March 2005
Rapid Response to Fluctuating Workloads
On Friday morning, 4th March, the snow fell thick and fast and we battled our way to the Novartis Foundation in London for the Senior CDM Forum
Panic set in following our arrival when we heard that Chris Hannigan, Kendle – our Keynote Speaker – was unfortunately stuck in the snow and unable to make it. However, Karen Smith was our subject-linked facilitator for the event and, with responsibilities for Organisational Development and Training at Kendle, she was very familiar with this subject! She had a quick run through from Chris over the phone and bravely agreed to step into his place.
Karen began the afternoon by describing how it is possible to get drugs to market a whole 2 years faster1 by contracting work out to a CRO! Average development times were identified to be:
Phase I
88 weeks (sponsor) / 66 weeks (outsourced)
Phase II
139 weeks (sponsor) / 81 weeks (outsourced)
Phase III
140 weeks (sponsor) / 97 weeks (outsourced)
Total (Phases I, II and III)
367 weeks (sponsor) / 244 weeks (outsourced)
difference = 123 weeks
Karen moved on to describe in more detail the Insourcing Model, whereby CRO, freelance or agency staff are placed in house at the sponsor site to aid drug development.
Different costing models were described – salary based, team based and transparent and inclusive pricing. Advantages of the insourcing approach were described as including tailored line management – to suit the sponsor – and client dedicated, motivated and fully trained personnel with low attrition rates. Advice was also given on how to select the best suppliers of staff – to provide a rapid response, flexible contracts and an understanding of the legal environment affecting the provision of contract staff.
After a short break, we moved on to Daljit Nakhwal, Covance, who described a case study of personal experience in providing a rapid response. Daljit began by describing his building blocks for a rapid response:
Trial Characteristics
It is important to be able to predict CRF flow, number of queries, number of serious adverse events, etc. Daljit noted that it is possible to use statistical modelling to predict such figures – find yourself a friendly statistician!
Market Place
Knowledge of the market place is essential to be able to respond rapidly and appropriately, for example to prioritise query generation with respect to public holidays affecting site location.
Client and Partners
It is important to gain knowledge of clients and partners – for example third parties such as central laboratories, etc.
Tools and Systems
An understanding of the systems being used is vital, particularly with respect to global systems, access capacity and workload versus resource distribution.
Metrics and Deliverables
Availability of reliable status reports is essential to enable tracking of progress versus deliverables. Daljit suggested tracking planned CRF flow versus actual and also number of queries raised versus number resolved, noting that a target resolution rate of 95% is essential as database lock date approaches.
Daljit then moved on to discuss essential elements to ensure a reliable and rapid response to fluctuating workload, including:
succession planning within projects
assessment of team capacity (consider holidays and sickness)
provision of "in time" training
consideration of team saturation and breakpoint
Finally, the development of self managed teams was described – to ensure they can manage without you so you, too, can go on holiday!
After Daljit's presentation it was time for pre-dinner drinks and networking to continue our discussions on this important topic, followed by our evening dinner before the return home through by now mostly melted snow. An excellent and informative afternoon!
Gill Lawrence, Kendle
References: 1Barnett International Benchmarking Group
The ACDM Senior Forum is open to all ACDM members who have at least 5 years experience in Clinical Data Management, plus some line and/or project management experience.
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