Elevating Clinical Services from Outsourcing to Collaborative Partnership exemplified by EMD Serono case study 29 January, 2013

Transcription

1 Elevating Clinical Services from Outsourcing to Collaborative Partnership exemplified by EMD Serono case study 29 January, 2013 Michael Weitz Cytel Inc.

2 Outline Intro About Cytel and lessons learned along the way Global outsourcing trends beyond cost advantages EMD Serono case study Conclusions & your questions

3 From Statistical Software Company to Global Functional Services Provider How did we get here? Cytel in 2004 was a software company. Paris Cambridge Geneva Today we re a statistics and clinical data services company providing functional services & software to pharma, biotechs, device developers around the world. San Francisco Philadelphia Pune Hyderabad Collaborative development example Awarded a CRADA (Collaborative Research and Development Agreement) 2009 with FDA CDRH to create much needed reliable, commercial software for designing Bayesian adaptive trials especially for device clinical research.

4 Global Trends Enabling Outsourcing Moore s Law at work Then imagine those 1.3 billion people fitting into the original music hall. Graphic courtesy Intel

5 Labor Arbitrage & Communications Trends Chief economist with Morgan Stanley, Stephen Roach defines labor arbitrage occurring when barriers to international trade are lowered. Barriers to the trade of intellectual work - essentially, work performed on a computer - have been greatly reduced by: The advent of high speed/capacity internet Much lower costs of telecommunications Secure and near-instantaneous document transfer There s no turning back we re in an age of distributed accomplishment it must be truly collaborative to be effective, worthwhile

6 Start Up Time vs. Wage Inflation IN INDIA Average Wage Inflation = 15% in 2010 * IT & Healthcare Sectors are running as high as 25% in some cities Talent shortage and cost of living inflation (esp. Mumbai, Bangalore) If Rupee slumps against USD$ as in 2010 matters get worse for outsourcing cost advantage UNIVERSAL Retaining best employees requires continuous training, career paths, promotions a genuine focus on individual and team morale * According to Mercer

7 Declining Wage Gap India USA

8 Anticipating Challenges in High-Skillset Collaborative Clinical Projects What are the baseline challenges? 1. Startup disruptions to sponsor staff 2. Building a qualified, compatible remote team 3. Integrating sponsor and outsourced personnel 4. Communication it never ends 5. Adaptation adjusting to changes, evolution 6. Retaining, growing the remote team

9 Define Qualified Know What You Need Assessing team members appreciate delta Qualified vs. Experienced Experienced vs. Skilled Skilled vs. Capable Capable vs. Trusted

10 Boosting EMD Serono s Biostatistics & Programming with an Extension Arm Sponsor s Challenge EMD Serono is conducting clinical studies in multiple therapeutic areas, including oncology and multiple sclerosis. They seek a flexible, scalable resourcing model to meet additional R&D demands without raising head-count. To increase biostats and programming capacity, EMD Serono turns to Cytel. The Cytel-staffed extension arm must: lower costs, yet deliver qualified clinical stats and SAS and R talent adhere to EMD Serono standards limit start-up disruptions

11 Creating the External Arm Team-building for EMD Serono Assemble qualified team Cytel assembles a team of qualified biostatisticians and SAS and R programmers from our Indian offices. Co-develop start-up strategy Construct a plan addressing typical outsourcing challenges especially requisite skill level fulfillment and synchronizing distributed work centers. Monitor and adapt Carefully monitor progress and quality of extension team s work by both Cytel and EMD Serono managers.

12 Minimize Startup Disruptions Thoroughly specify performance criteria from the start

13 Co-Develop Governance in Detail

14 Collaboration Outcome: Flexible Stats & Programming Capacity The EMD Serono project is reaping benefits following start up effort completion. Together, we anticipated and tackled early challenges. The increasing biostats and programming productivity with our dedicated Cytel staff means EMD Serono is handling their workload increases. Ajay Sathe Chief Executive, Indian Operations Outcomes The extension team is now functionally integrated with EMD Serono s own biostatisticians and statistical programmers in Europe and the US. The additional resources also can scale to cope with future resource bottlenecks anticipated or unforeseen.

15 Added Collaborative Approach Benefits Intangibles that Matter 1. Routine task automation Automate time-intensive computational and clinical data-handling process chores, stemming from: Result from continuing Cytel commercial software development CDISC expertise dataset migration, verification, submission prep 2. Independent peer validation Ongoing collaboration with fellow experts helps sharpen sponsor s own biostats and data processes and practices. 3. People you trust, who know you provide the best advice

16 Conclusions Clinical research functions are increasingly distributed its a fact of life today Don t just play the arbitrage game it s short-sighted, dangerous Don t think clinical offshoring is easy and that anyone can do it ask how? probe the answers and the people Appreciate that on-going communication is key to success assess transparency, not just training and education Cultural differences can undermine understanding, performance how does the outsourced leadership address it? Meticulous planning: think together and detail desired outcomes clearly spelled-out, shared expectations are essential

17 Thank you. Your comments or questions? 29 January, 2013 Michael Weitz Cytel Inc.

18 Global Driving Trends

19 How Did We Get Here? PUNE TO HYDERABAD