Spring 2006
Building and Managing Biometrics Activities Offshore
Presented by Tom O’Leary, ICON Clinical Research
ABSTRACT
Tom presented an overview of ICON’s recent experiences of setting-up and establishing offices in new, unfamiliar locations. This was an interesting and informative presentation, with plenty of tips and considerations when establishing a new office. Starting with background information around the rationale and impetus to offshore, Tom went on to highlight key criteria that should be considered when selecting a potential location. These were:
1. Critical: cost, technical skills of workforce, language skills, telecommunications quality and capability
2. Other: proximity to international airport, living conditions, local employment laws, property costs, wage inflation, personal safety, quality of life, data security, e-readiness ranking.
As you can see, quite a list of considerations! The impetus to offshore was driven predominately by the need to have flexibility in resource and “chasing the sun” data processing i.e. the need to manage and process data globally without time difference issues and pressure to reduce costs.
ICON’s initial strategy was to off-shore non core work as a low risk approach. Other areas of corework can be sent offshore once the company is comfortable and clear about the quality and communication of the offshore relationship. This included Data Entry and DBA activities, with all programming work checked by the core office until quality and experience was established.
HR and recruitment strategies were also critical to successful set-up of a new office, alongside the importance of local knowledge, understanding of customs and cultures in the workplace and having a local consultant to advise, guide and overcome language barriers, advise on local regulations and vendor regulations.
Training to new staff was critical, thorough training required to be given to all new starters, general training to include company culture, email etiquette, etc but also in GCP, CDISC, importance of quality, SAE reporting process and not forgetting technical systems and process training and also soft skills training. Initial intensive training is essential and should be fully supported and resourced by qualified trainers, ensuring follow-up training and checking of quality of work.
Overall, ICON’s experience of establishing an offshore office highlighted key learning points for future consideration. It is essential to have a clear strategy and project definition, communication is key, management challenges need to be considered up-front and training and strong reporting lines are critical to success.
Lisa Goodwin
AstraZeneca