1. Clinical Trial Redesign Update: Intake process
SMART Meeting
May 16, 2017
At this time, changes will apply to industry-funded clinical trials handled by RMG, not including CCTO.

2. Timeliness Metric and Satisfaction Scores:
Success and room for improvement
HIGHER = BETTER
LOWER = BETTER
Lean Process Improvement
-Introduced concept of KO meetings to improve working relationship between RMG and study teams and to improve timeliness
-Success seen in improved relationships & positive feedback from study teams on a range of issues, including effectiveness, timeliness and communication.
-Overall improvement in timeliness not seen
Measuring time from RMG’s receipt of “first actionable item” to Award set up
Focus on internal processes
Ask question…why studies “get stuck” during budget development after KO meetings??
Answer – variations in the level of readiness and use of time -at KO meetings
As a collaborative effort, work flows best when all information is readily available at KO meeting
Baseline = Pre-Lean (FY 2014). Lean = December 2015 through January Excludes studies that fall outside these tracks (approximately 10%).

3. Refining the Intake Process: Synchronize Workflow of Study Team and RMG
Current Process
Rework and revisiting study documents extends time required to send proposal to sponsor
Meeting
CT RPM & CT CO
New Protocol
Draft budget /
Contract Review
Sponsor’s Payment Schedule
Editable contract
Completed Budget Questions Form
Completed Study Workbook
We looked at our Clinical Trial Intake Process and discussed how to refine it, in order to improve our collaborative efforts with research teams.
The study start up process is initiated by receipt of the study protocol
Even though we know there is variability in the readiness of study teams when a new protocol is received, currently the first step in RMG is to confirm with the study team their assigned CT RPM and CO and then to schedule KO meeting ASAP
We have seen a lot of variability as to what can be accomplished at the KO meetings and the biggest contributing factors are the study team’s readiness and the availability of required documents– see list
Since often these required documents are not available at KO meeting, rework and revisiting of study documents, as noted by the red dots on timeline, takes place in both RMG and in study teams when these documents are obtained, completed or revised
Work flow is often piecemeal and fragmented by missing information or by a need for clarification or feedback
Frequently work flow of study start up process becomes stuck and the first draft of budget or contract review can be delayed for many weeks after KO meeting
Our goal when reviewing the Intake Process was to maximize the benefits of study KO meeting by synchronizing workflow of study team and RMG.
Draft budget
Contract Review
New Process
Meeting
CT RPM & CT CO
New Protocol
Goal: 2-4 weeks to send proposal to sponsor

4. Refining the Intake Process: Synchronize Workflow of Study Team and RMG
Current Process
Rework and revisiting study documents extends time required to send proposal to sponsor
Meeting
CT RPM & CT CO
New Protocol
Draft budget /
Contract Review
Sponsor’s Payment Schedule
Editable contract
Completed Budget Questions Form
Completed Study Workbook
New Process:
With this new Intake process our goal is to bring RMG and study teams in sync so work flow is steady and efficient
Once all required documents have been received - CT RPM/CT CO assignment will be confirmed and KO meeting scheduled
While required documents are gathered and prepared by study team, CT RPMs and COs are readily available to answer questions and assist
Erin has developed new training modules for budgeting clinical trials and it will be rolled out by SPECTRM next month
With this refined process, the CT RPM team’s attention will be focused on studies ready to go with both the study team and RMG will be in sync and fully engaged in work flow, as noted by the steady stream of green dots
Everyone can review documents as a package in advance of KO meeting; CT RPM can prepare a draft budget to review together and questions can be addressed in real time
Goal is to use everyone’s time efficiently at meeting and avoid future rework and revisiting of documents
With this revised approach we expect to send a budget proposal to sponsor within 2-4 weeks after meeting
Draft budget
Contract Review
New Process
Meeting
CT RPM & CT CO
New Protocol
Goal: 2-4 weeks to send proposal to sponsor

5. Refining the Intake Process: Synchronize Workflow of Study Team and RMG
Streamline and standardize intake process
Collaboratively work more efficiently – fewer breaks in work flow
Meetings - Better use of our time together and set realistic target dates
Reduce start to finish turn-around time
July 1st Roll Out
By streamlining and standardizing the readiness of study teams when CT RPMs and CO engage with them, we anticipate that we will be able to work together more efficiently with fewer breaks in our work flow.
When we meet, we will be able to discuss and resolve questions raised by review of the study documents – avoid rework and a fragmented piecemeal approach to the study start up process
Since there will be less missing information, it will be much easier to set realistic target dates
End result: improved timeliness