Your dream outcome. Helping cancer patients. Doing it right. Recruiting quickly and efficiently and getting a diverse population into your study. You have noble intentions and great science.

So – why are you accumulating months delay even before the first patient is recruited?

There are a lot of things on the science and recruitment side, that can go wrong to make your achievement less likely.

But how about controlling the factors that ARE under your control and that can reduce time delays and the amount of effort and sacrifice you’ll have to go through in order to succeed in your study.

Spoiler – process excellence is the whole story. NOT DCT features.

You don’t want to wait for the last minute

This post is dedicated to all the tireless researchers and fearless entrepreneurs who drive biotech and medtech forward.

There are over 60 blockers waiting for you

So hold on to your hats!

Before the contract

What is your perceived likelihood of starting the trial on-time before the vendor contract.  Well, there are a dozen reasons for not starting the study on time even before you sign the contract. None of these reasons have anything to do with the latest DCT technology or diversity in recruiting. They are the facts of life of clinical trials.

1. Lack of experience in clinical trials
2. Uncertainty regarding choice of CRO (or DIY)
3. Uncertainty regarding  regulatory pathway 
4. Uncertainty regarding the SAP 
5. Uncertainty regarding the data management plan
6. Uncertainty regarding the study design/protocol
7. Uncertainty regarding the CRF/data model
8. Uncertainty about when the study will start / end
9. Uncertainty about probability of success 
10. Uncertainty when IRB approval will be received
11. Uncertainty regarding sites
12. Uncertainty regarding patient recruiting

What about time delays at the time of the contract?

13. You have IRB approval but the DCT vendor features need to go back for approval?
14. Are you working with a consultant who is not a decision maker? Who makes the decisions on price, features and scope of work? The CEO, the consultant or the VP Clinical?
15. Do you have uncertainty regarding total cost of ownership of the project?
16. Are you unsure about the impact of changes in your CRO contract?
17. Are you still trying to get the lowest price
18. Is the quote process taking your time and your management attention away from fund raising?

19. Are you still having delays agreeing on  the contract with the eClinical vendor?
20. And then there are delays signing the contract due to lawyers on both sides.

After signing the contract 

Designing the cloud data collection, monitoring, and data management system

The time delays from your CRO and EDC vendor continue to frustrate you but it’s hard to keep up

21. You are losing total attention to the process; it’s hard and you’re busy running the company
22. You need to make changes to protocol / CRF after the vendor quote
23. Your clinical team decided to change document/protocol names
24. This created mismatches between the protocol and the CRF
25. And generated lots of email traffic which creates more confusion and delays

Your perceived likelihood of achievement is not improving; you have a contract but you may still fail.

26. You have uncertainty regarding the risk assessment of the study protocol – your CRO wants more money and recommends a RQBM vendor, which layers more costs and delays
27. You lack of clarity regarding GCP risk –  targeted SDR or 100% SDV ? 
28. What GCP monitoring alerts does your clinops need?
29. What DM reports / additional Study tools are needed to run the study?
30. Your consultant is not available for feedback; they went on vacation for a week.
31. There is still vagueness regarding randomization and supply chain (RTSM)
32. Your team is waiting approval of edit checks
33. Your ePRO was never validated with patients before the system was onboarded!!
34. Your eCRF was not validated with site coordinators/investigators before onboarded

Implementing the cloud data collection, monitoring, and data management system

So we got past the contract, the lawyers and we’re ready to start building the EDC. Yes, there will be more time delays due to poor project management process

35. The cycle time for designing the clinical data model? 
36. Cycle times for eCRF, DM tool development, data extract validation?
37. Turnaround time for development of edit checks
38. Internal EDC team delays
39. Perception that EDC team not updating you on regular basis
40. Perception that project is delayed due to EDC vendor execution
41. Delays and changes during UAT

Your perceived likelihood of achievement is still not getting better- you may still fail even after study build

42. Unclear impact of changes in protocol and CRF during development
43. Multi-lingual support for non-English-speaking patients
    

Did anyone on the vendor team think through all the data management tools you might need?

44. What additional DM study tools could you have have that would save time and money downstream? You didn’t think of asking….
45. There appears to be vagueness around data manager responsibilities

After building the EDC 

The of starting on time is still vague – you may still fail.

46. You need training on EDC and Flask CTMS 
47. You are waiting for the last minute for training
48. You are not getting sufficient training for user management/patient management
49. You are not getting sufficient training for EDC administration
50. You are not getting trained on CTMS
51. You don’t have SSO between the CTMS and the EDC
52. The sites still don’t know to use the mobile ePRO app
53. The sites still don’t have test accounts for ePRO
54. The training video for the ePRO is not in Spanish and it’s for an older version

Wait a minute – what kind of effort & resources do we need for statistical reports?

55. I pay a lot of money to my study statistician / data manager for reports
    

There will always be time delays to close out the study – why can’t we get this right for once?

56. You run into delays due to technical issues with the statistician being able to parse data extract files
57. You never thought of doing a test run for the statistician
58. Your protocol amendments were not properly documented and implemented in the EDC
59. Your Investigators/monitors are not able to login because accounts were locked or they forgot how to use the system

And there are more time delays to get status of data quality, patient safety, and protocol compliance

60. You need some special reports – that means that you need someone else extract data, process and prepare the report for you
61. Your statistician uses SDTM format, that adds a another 3-5 weeks to the wait

So delays happen. And costs mount up. And CRO overheads mount up. And absolutely none of these delays have absolutely anything to do with DCT technology.

You can be sure that the VC’s that put money into DCT vendors never considered the fact that process excellence is the whole story.