1、White PaperOptimizing Clinical Trial Startup Times:Competing on Contracting EfficiencyDR.KAI HNEL,Associate Director,Global Site ActivationMEIKE MADELUNG,Engagement Manager,EMEA Thought LeadershipDR.MARC ROHDE,Director,Strategic Site SolutionsTable of contentsPreface:Advancing Germany as a trial loc

2、ation together!3Executive summary 4Country trends in clinical trials 5Political environment 7The impact of contracting templates and harmonized 8 budgeting on cycle times across Europe Case Study:Introduction of standard contract clauses in Germany 10Conclusions and recommendations 12Acknowledgement

3、s 12References 13 |1Preface:Advancing Germany as a trial location together!Germany has long been well positioned and internationally competitive as a location for conducting clinical trials.This was reflected in its position as number one in Europe and number two worldwide,behind the USA,in terms of

4、 the number of clinical trials conducted.Unfortunately,this is no longer the case.Some indicators show that several countries,including in Europe,are overtaking Germany as a preferred location for clinical trials.It is in the common interest of all those involved in clinical research in Germany pati

5、ents,trial centers,CROs and clinical trial sponsors to regain a leading position.Representatives of various stakeholders in the field of clinical trials have joined forces to pursue these common goals:The Association of Medical Faculties(MFT),the Association of German University Hospitals(VUD),the C

6、oordination Centers for Clinical Trials(KKS Network),the Federal Association of Medical Contract Research Organizations(BVMA),the Federal Association of the Pharmaceutical Industry(BPI)and the Association of Research-Based Pharmaceutical Companies(vfa).Together,they have published joint model contra