3 Pam Howard ICON Clinic al

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Strategies in successfully initiating and building an offshore unit in India

Strategies in successfully setting up an Offshore Biometrics unit: 

Strategies in successfully setting up an Offshore Biometrics unit What is clinical research ICON – company and culture Background to the business decision regarding offshoring Criteria considered in choosing a location HR and recruitment strategies Importance of local knowledge Strategic dilemmas and management challenges Training Flexibility within boundaries

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What is clinical research?

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WHAT IS CLINICAL RESEARCH? Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy.

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Drug Development 1 In 10,000 Succeed (to market) Average Time: 12 Years Average Cost: €250 Million (approx.) 100,000 New Chemical Entities Preclinical Evaluations 100 Tested in Humans 10 Marketed Drugs 2 Drugs Return a Profit

Drug Development: 

Drug Development 3 - 7 YEARS APPLICATION FOR A PRODUCT LICENCE (PL) Discovery Pre-Clinical Testing Investigational New Drug Exemption Human Clinical Trials PHASE I (first time in man) PHASE II (first time in Patients) PHASE III (Larger scale, safety and efficacy) Approval and Phase IV

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ICON Company and Culture

ICON Snapshot: 

ICON Snapshot www.iconclinical.com Founded in 1990, in Dublin Over 2,700 employees worldwide Offering full spectrum of clinical development services In the top 5 largest Clinical Research Organisations (CROs) in the world Over $320m in Net Revenues 37 offices in 23 countries on five continents Built on over 90% repeat business

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Offices: US www.iconclinical.com www.iconclinical.com

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Offices: Europe www.iconclinical.com www.iconclinical.com

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Buenos Aires Johannesburg Montreal Mexico City Sao Paulo Taipei Seoul Bangkok Singapore Chennai Bangalore Tokyo Osaka Hong Kong Beijing Sydney Offices: ROW

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www.iconclinical.com Full Service Drug Development 6% Strategic Drug Development and Regulatory Consulting (US & EU) 5% Phase I 8% Central lab (Global) 16% Data Management & Statistical Consulting (Global) 57% Trial Management & Monitoring (Global) 2.5% Contract Staffing (US) 2.5% Central Imaging Lab (US & EU) 3% IVRS (Global)

Differentiators: 

Differentiators Commitment to quality Impeccable reputation ISO quality certification Global systems/procedures and quality standards Dedicated clinical team concept Organic growth in clinical research group Strong training programs www.iconclinical.com

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Background to business decision regarding offshoring

Strategic Business decision: 

Strategic Business decision

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GLOBAL BIOMETRICS DATA MANAGEMENT Biometrics & Full Service Data Management Data Management Support Offices

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ICON’s Imaging/Workflow system Scanned images available in remote offices Paper remain in core offices Images linked directly with ICON’s data management system Imaging software allowing location independent data processing (flexibility and continuity) ICON Technology - OptICON

Why was Data Management suitable for offshoring?: 

Why was Data Management suitable for offshoring?

Why move data management offshore?: 

Why move data management offshore? Piloting process improvements Pressure to reduce cost Impetus to move offshore Resource flexibility “Chase the sun” processing of data www.iconclinical.com

Processes to move offshore: 

Processes to move offshore Initially, chose to offshore activities over which the “core” offices would have a large degree of control Data entry – single entry done by offshore location, double entry done in the core office DBA activities – initial programming done by offshore location, checking of programming done by core office www.iconclinical.com

Summary: 

Summary ICON’s initial strategy in offshoring Activities Data entry Programming activites Structure Offshore location as back office Core DM offices involved in client interaction / control Technology Global data management system

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Criteria considered in choosing a location

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Commisioned external international consultants to help with location decision – report provided Cost Technical skills English/communication skills Telecommunications quality Competition for skills International airport Living conditions Staff employed normal working hours / full time positions Criteria considered in choosing a location Critical factors Other considerations:

Some other criteria considered in choosing the location: 

Some other criteria considered in choosing the location

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Singapore benchmark Locations considered Manilla, Phillipines KL, Malaysia Dehli, India Mumbai, India Chennai, India Hyderabad, India Criteria considered in choosing a location

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Locations considered

Weighted Quality Cost Map: 

Weighted Quality Cost Map Source: Consultancy report for ICON Weighted quality score Infrastructure Country-specific risks Time zone attractiveness Operating cost Index Costs of resources Wage inflation Property

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Actual visit to the various locations essential Quality of life Traffic Initial contracts with Estate agencies Recruitment agencies Consultants Enterprise agencies IT vendors Other contacts Final location chosen - Chennai Criteria considered in choosing a location

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ICON OFFICE – CHENNAI - ISPAHANI CENTRE

ICON’s history with India: 

ICON’s history with India

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HR and recruitment strategies

HR and recruitment strategies: 

HR and recruitment strategies Recruitment strategies Recruitment agencies All claimed to have “large databases” Not the same level of customer service as Europe Pushback required on Payment terms (5 working days?) Recruitment fees (can be negotiated) Usual that there is some wording regarding not poaching the staff that are being procured Screening of CVs not optimal by HR agencies As they may be used to recruiting for call centres hundreds of staff at a time, need to sell what is in it for them Advertising worked to a limited extent Word of mouth – excellent strategy for attracting staff

HR and recruitment strategies: 

HR and recruitment strategies Recruitment strategies Interviewing Times of interviews not taken with the same level of seriousness as in the West Useful to have Indian nationals also present at the interview Honesty about the expectation of the position and the type of work that was going to be done Same criteria used globally for standard positions – education levels, job descriptions, technical skills etc… Acceptance of job offers Family acceptance of job important Contractual issues Having a good office location / pleasant surroundings Need to push recruitment agencies to follow up on candidates

HR and recruitment strategies: 

HR and recruitment strategies Retaining staff “If it ain’t broke why fix it….” Staff in India are treated consistently with staff in any other ICON office Same career structure / job descriptions Same training and development Same HR policies and procedures Same promotion of company culture Same communication lines… “Proof of the pudding….” No staff turnover since the Chennai office opened in Sept 04. Note: Staff turnover in India over 50% would not be uncommon depending on the Industry sector

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Importance of local knowledge

Importance of local knowledge: 

Importance of local knowledge Local consultant to help with the initial set-up Very status conscious culture Match seniority in negotiations / meetings Vendor negotiations Understanding of local laws / customs Contacts with local agencies / embassies etc

Importance of local knowledge: 

Importance of local knowledge Communication with/within the Indian office “Remote and virtual team” training for staff liaising with the Indian office Indian management in the office Interviews Respect for local traditions / holidays

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Strategic Dilemmas and Management Challenges

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Communication Communication Communication

Communication with staff in core ICON offices: 

Communication with staff in core ICON offices Let staff know as soon as plan to offshore was confirmed: Rationale why looking at offshore location Indicated timelines Showed how it would help them Dealt with any queries Regular agenda items at staff meetings Strategy within ICON remained consistent Communicated with different departments also within ICON

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Communication Project teams Support groups Dublin / IT / HR Corporate training Responsible manager / core office Global DM management Senior management Biometrics Management India Finance Sponsors audits / outsourcing / operations Staff in the India office

Clear reporting lines essential : 

Clear reporting lines essential Project management of the “India” project Training /IT / HR / Finance support India reports into Europe Accountability and responsibility Time zone compatibility www.iconclinical.com

Management communicationsWhat works…: 

Management communications What works… Frequent visits to the offshore office Secondment of staff to the offshore office Visits of remote staff to the core offices Scheduled daily calls to the remote office Project reporting Regular scheduled call with remote support departments

Management challenges resulting from offshoring decision: 

Management challenges resulting from offshoring decision

Management challenges resulting from offshoring decision: 

Management challenges resulting from offshoring decision

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Training

Training courses: 

Training courses Processes Data entry Validation (initial and 3 day training course) Coding Role of DBA / Data Entry / Data management External data reconciliation Technology Oracle Clinical / level depending on job role OPTICON – workflow and scanning General Industry / company culture 21 CRF Part 11 ICH/GCP CDISC Importance of quality SAE for non-clinical personnel E-mail etiquette Communication etc Soft skills training… Initial and ongoing training is essential

Process definition: 

Process definition Essential that staff in India received intensive, comprehensive training Positives Already knowledge within the Indian team Remote training Defined training modules for different DM roles Staff from cores offices willing to travel and give training Hints Follow–up on training and checking quality essential Clearly define quality and efficiency expectations Measure daily progress Positive as well as negative feedback Training delivery needs to be matched to the stage in the process “Train the trainer “ effective

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Flexibility within boundaries

Flexibility: 

Flexibility Give some leeway for the group to learn Be positive regarding what has been achieved as well as clear regarding any issues which arise Listen to what the staff are saying Working Saturdays Support the cricket team !!

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Summary

Summary: 

Summary A clear strategy / project definition is essential for successful offshoring Communication is key Management challenges need to be considered up front Training / and strong reporting lines

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Strategies in successfully initiating and building an offshore unit in India