Assessing the Quality of {Company s} Rela8onship with its Inves8ga8ve Sites A=er Conduc8ng a Study. {Date}
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1 Assessing the Quality of {Company s} Rela8onship with its Inves8ga8ve Sites A=er Conduc8ng a Study {Date} 1
2 Table of Contents Project Background Business Objec9ves Survey Methodology Execu9ve Summary Overall Rela9onship Quality Ra9ng Training Evalua9on Sponsor Contact Diagnos9cs - Project AOributes Clinical Research Process Benchmark Analysis Background Slide #
3 Project Background {Sponsor Company} conducted a clinical study (ies) {domes9c and/or interna9onal} {Protocol Title}, las9ng X weeks. The study(ies) were completed in {Year} and involved X number of pa9ents. Some of the challenges associated with the study included: An extremely complex protocol The requirement of a high level of pa9ent care The use of new EDC technology 3
4 Business Objec8ves Given the complexity of the protocol and the various study challenges, {Sponsor Company} was interested in: Assessing how inves9ga9ve sites perceive their overall rela9onship with {Sponsor Company}. Determining how {Sponsor Company} performed as a clinical trial sponsor: Specifically, determine areas of strength and areas where improvement is necessary. {Sponsor Company} intends to apply the learning from this research to future clinical studies. 4
5 Survey Methodology Base survey instrument ini9ally developed by CenterWatch for its global sponsor/ contract research organiza9on and site rela9onship surveys. This base survey instrument was then customized with {Sponsor Company s} input to produce the final ques9onnaire. Survey conducted online in {DATE}. Survey ed to X number of inves9gators and study coordinators worldwide. Final sample size was n=x, indica9ng a X% response rate. Respondents had an average of 10 years clinical research experience The final sample was composed of: 39% Inves9gators 60% Study Coordinators 5
6 Execu9ve Summary Overall, inves9ga9ve sites rate the quality of their rela9onship with {Sponsor Company} highly and enjoy working with the company as a clinical trial sponsor: The suppor9ve, knowledgeable and professional staff, as well as the crea9on of a team environment primarily drove posi9ve percep9ons of the company. When compared to previous CenterWatch inves9ga9ve site surveys conducted in the US and Europe, {Sponsor Company} overall rela9onship quality ra9ng surpasses the average sponsor ra9ngs. Study coordinators and inves9gators share the same posi9ve percep9ons of {Sponsor Company}. 6
7 What Worked Well Training programs achieved strong ra9ngs. The inves9gator mee9ng and the Workshop were rated par9cularly highly. Sites also perceived {Sponsor Company} to communicate effec9vely - responding to inquiries in a 9mely manner and generally being sa9sfied with the responses to their inquiries. The Electronic Data Capture technology was perceived to be very user- friendly, regardless of one s experience level with EDC. 7
8 What Worked Well (cont d) On specific project aoributes, {Sponsor Company} performed par9cularly well in these areas PERSONNEL Professional and knowledgeable staff Informa9ve inves9gator mee9ngs STUDY INITIATION AND MAINTENANCE Timely drug availability Study- related materials readily available Study Reference Guides provided and updated 8
9 Improvement Areas While most were generally very sa9sfied with their experience with {Sponsor Company}, it is worth no9ng that issues were expressed in the following areas: High monitor turnover Infrequent monitoring visits Quality issues with third par9es: {X Company} (delayed lab results and poor responsiveness to inquiries) {X Company} (high monitor turnover) Lack of flexibility with the budget, especially in cases where the study is extended EDC: A few men9oned some difficulty entering correc9ons in the system and some experienced issues with the speed of the system (i.e. opening the program). 9
10 Improvement Areas On specific project aoributes, there is room for improvement in these areas FINANCIAL CLINICAL DATA MANAGEMENT Willingness to modify study budgets Fairness of grant payment amounts Promptness of grant payments Provide adequate funding for pa9ent recruitment Efficiency of the query handling process PERSONNEL Monitor turnover 10
11 {Sponsor Company} OVERALL RELATIONSHIP QUALITY RATING 11
12 Overall Ra8ng of Rela8onship Percent Ra8ng 100% 42.3% 75% 50% 41.3% 25% 0% 16.3% 0% 0% (n=104) *May not add up to 100% due to rounding Excellent Good Average Fair Poor 1 Poor Mean Ra8ng Excellent Respondents rate their overall rela0onship with {Sponsor Company} as Good to Excellent. 12
13 General Rela8onship Quality Drivers LIKES DISLIKES SUPPORTIVE, PROFESSIONAL AND KNOWLEDGEABLE STAFF/READILY AVAILABLE/FELT LIKE PART OF TEAM REALISTIC, WELL- DESIGNED PROTOCOL 73.0% 9.5% NONE MONITOR TURNOVER/INFREQUENT MONITOR VISITS/LACK OF IMMEDIATE ASSISTANCE 64.7% 11.8% GREAT COMMUNICATION/ INFORMATION SHARING AVAILABILITY AND QUALITY OF TRAINING PROVIDED OTHER 7.9% 6.3% 3.2% QUALITY ISSUES WITH THIRD PARTIES LACK OF RESPECT FOR SITES/OPINIONS OF INVESTIGATOR OTHER 7.8% 5.9% 9.8% The professionalism, friendliness and responsiveness of the staff, as well as the crea0on of a team environment, primarily drove posi0ve percep0ons of {Sponsor Company}. While most respondents did not men0on any dislikes, some expressed issues with monitor turnover/lack of monitoring visits, quality issues with third par0es involved and the occasional lack of respect for the judgment of inves0gators. 13
14 {Sponsor Company} TRAINING EVALUATION 14
15 Training Evalua8on Respondents rate all training programs favorably, with the inves0gator mee0ng and the Workshop ranked highest. TRAINING TYPE Inves9gator mee9ng Workshop Training on study specific procedures Ini9a9on visits Training on worksheet comple9on (SAE, weight & dose calcula9on worksheet) Training on EDC technology Source document verifica9on (SDV) data review process Disease ac9vity proficiency test On- site GCP training Poor Mean Ra8ng Excellent
16 {Sponsor Company} SPONSOR CONTACT 16
17 Sponsor Contact During Studies Was the number of different personnel who contacted you during studies Don t Know Too 5.7% Low 10.2% 5.7% Too High On average, how many 8mes a month were you in contact with {Sponsor} or designee in a typical month? Mean High Low Times per Month % Just Right Most respondents perceive the number of personnel who contact them during studies appropriate. The frequency of contact varies, averaging 3 0mes a month. 17
18 Measuring Communica8on Effec8veness: Timeliness of Responses to Communica2on from Site Percent Ra8ng 100% Mean Ra8ng % 50.0% 1 5 Excellent 50% 25% 0% 27.3% 18.2% 2.3% Timeliness of Responses 0% Good Average Fair Poor Poor Excellent Most respondents perceive {Sponsor Company} to respond to inquiries in a 0mely manner. 18
19 {Sponsor Company} DIAGNOSTICS PROJECT ATTRIBUTES 19
20 Project Ahribute Summary Improvement Areas Areas of Strength ü Flexibility willingness to modify study budgets ü Providing fair overall grant payment amounts ü Monitor turnover ü Query handling process ü Providing prompt payment of grants ü Providing adequate funding for pa9ent recruitment ü Professional and knowledgeable staff ü Providing appropriate inclusions/ exclusions for disease under study ü Timely drug availability ü Study- related materials readily available ü Study reference guides provided and updated as necessary ü Informa9ve inves9gator mee9ngs *No significant differences were found between the inves2gators and study coordinators across all project aaributes. 20
21 {Sponsor Company} CLINICAL RESEARCH PROCESS 21
22 Electronic Data Capture Technology: Percent Ra8ng 100% Ease of Use Mean Ra8ng 75% 36.7% Extremely easy to use Very easy to use % 25% 0% 34.2% 24.1% 2.5% EDC 0% Easy Somewhat not easy to use Not easy to use at all Not easy at all Extremely easy While most respondents perceive the electronic data capture technology to be user- friendly, some indicated issues with entering correc0ons/revising data. 22
23 Looking Ahead: Improvements for Future Studies Half of respondents had a great experience overall with {Sponsor Company} and did not have any recommenda0ons for the future. 15% recommended reviewing/upda0ng the budget when a study extension occurs. Finally, some expressed dissa0sfac0on with {Company} for high monitor turnover and (Company} for delayed laboratory results. OVERALL GREAT EXPERIENCE NO RECOMMENDATIONS SHOW FLEXIBILITY WITH REGARDS TO BUDGET - ESPECIALLY IF STUDY IS EXTENDED LESS MONITOR TURNOVER/ISSUES WITH INTERMEDIARIES OTHER: 51.9% 14.8% 11.1% 22.2% Early feedback in protocol process reduces amendments later Design a simpler protocol and CRF Training for new coordinators (site may not provide adequate training) Involve inves9gators more in data analysis and presenta9on 23
24 Par8cipa8ng Countries Country Country United States 39.4% Australia 1.4% Argen9na 8.5% Chile 1.4% Brazil 8.5% Colombia 1.4% Taiwan 5.6% Czech Republic 1.4% Korea 4.2% France 1.4% Germany 2.8% Peru 1.4% India 2.8% Poland 1.4% Israel 2.8% Puerto Rico 1.4% Italy 2.8% Romania 1.4% Mexico 2.8% Spain 1.4% Philippines 2.8% Sweden 1.4% Canada 1.4% 24
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