COVID-19 Choosing an IRT partner


to extend team resources David Goldston, president, and Andi DeStefano, director of project management at Veracity Logic respectively, discuss the important steps in building a productive interactive response technology partnership.


An ideal interactive response technology (IRT) partner will make the complex process of subject and inventory management simpler and easier to manage, saving the project team and clinicians time so that they can focus on the study. The ideal partner should be flexible, supportive and adaptive to meet clinical research organisation (CRO or sponsor) needs, while maximising support for the investigative sites. So, when choosing an IRT vendor, look for capabilities that will augment the team’s situation and resources. Areas important to a good partnership include the process, system, financial terms and support. Partnering starts early, before the contract is even


I


signed. The signs of an effective working relationship can be evidenced during the demo and request for proposal (RFP) process. A good IRT solutions partner will respect confidential information, provide a demo and send a prompt response to the RFP.


The process Before sharing information, a key step in developing a good partnership is a confidentiality disclosure agreement (CDA). This protects the information shared by both parties; this typically follows the laws of the country where the IRT vendor resides. The IRT vendor will then provide a demonstration of the system. This is an important step as there are differences in system capabilities and how easy they are to use. Look for a clean interface and intuitive, user-friendly design – this will save the organisation training time and frustration. Some of the key questions one might want to ask


during the demo may include: 


How is the data displayed and exported; can it be accessed quickly and easily without using queries or another system to view it?


84 | Outsourcing in Clinical Trials Handbook


ncreasing demand for speed while achieving quality results has made partnerships an essential component of the clinical trial environment.


 





 


How is unblinded information managed to avoid unintentional bias or unauthorised unblinding? How will the team and site users be trained?


Is the data easily transferred to the chosen electronic data capture (EDC) system?


How easily can changes be made to the system? What type of end of study reporting is included?


There are many system questions to ask; the ideal partner will walk the organisation through their system and make sure to give the answers needed. The goal of the demo is to help evaluate if the system will fit the needs of the study requirements. A good potential partner will respond to the RFP with comprehensive information. They will look over the protocol or synopsis in the RFP and develop their proposal quickly – usually one to two business days .


System capabilities The IRT solution should include a range of capabilities adapted to the CRO’s/sponsor’s needs, as outlined in the synopsis. A well- designed IRT system includes a validated core system and modules that add specific functions, so the CRO will want to check to see if the IRT


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120