Working with Countries that are Difficult to Budget and Negotiate - Mitchell Katz January 10, 2012

1. Global Site Contract Cycle Time
Expectations by Country
Most Used Global Countries
Setting Appropriate Cycle Time Expectations
(Cycle Time Ranges in Total Days)
0-45 46-90 91-120 121+
ARGENTINA* AUSTRALIA AUSTRIA FRANCE*
BULGARIA BELGIUM* BRAZIL* ITALY
CHILE CZECH REPUBLIC CANADA SPAIN
COLOMBIA GERMANY* CHINA*
HUNGARY IRELAND FINLAND
INDIA* JAPAN GREECE
ISRAEL LITHUANIA MALAYSIA
PERU MEXICO PHILIPPINES
PUERTO RICO NETHERLANDS SINGAPORE
ROMANIA POLAND* S. KOREA
SERBIA RUSSIA*
THAILAND SWEDEN
UKRAINE SOUTH AFRICA
US (CENTRAL) UNITED KINGDOM
US (LOCAL)

2. Country Experience with Site
Contracting
 Russia, Poland  Belgium
 Will accept CRO or sponsor template  At least 3 agreements (Institution, Investigators,
 In Poland, need a final CTA before MOH submission Pharmacy)
 Brazil  Will use CRO or sponsor template but will need to
 Multi-party CTAs/back and forth modify for the 3 parties
 Access to drug an issue  France
 Argentina  Prefers using own template
 CTAs usually not an issue  Investigator and Institution have separate
agreements
 Costs are low
 No reference to US law or FDA regulations
 China
 Germany
 CTAS not an issue
 Accept no templates
 Costs are low
 Any new invention belongs to the investigator
 MOH rate limiting
 Latin America
 India
 Easy to negotiate
 Will accept CRO or sponsor template
 Chili and Peru have two party agreements (PI and
 2 party agreement (CRO and PI) – site does not sign CRO)
 Costs are low  Hospitals refuse to sign agreement
 Things move quickly  Clinical trial insurance not easy to obtain
 PIs don’t carry liability insurance