“I have total confidence that MedAssessment is going to get us closer to a faster approval and a solid, high impact, high quality safety profile.”
- VP Clinical Operations
"Using MedAssessment allowed us, as a pre-market small drug sponsor, to delay increasing headcount for pharmacovigilance activities.”
- VP Clinical Operations
“Most PV providers I’ve experienced seem to perform the activities mechanically. They clock in at 9, they clock out at 5 and in between they check boxes without making deeper, strategic connections.
MedAssessment is the exception.
MedAssessment asks and answers the key questions, such as, ‘what is involved in this safety activity that I should be paying more attention to? What else is the safety data story telling me?’
- VP Clinical Operations
“The combination of MA’s ability to hold the bigger safety story together with practical, efficient operations means quality you don’t get from other providers.”
- VP Global Clinical Operations
“It was big clinical program- studies being executed all over the world, many different regulatory considerations, monumental operational and data complexities. MedAssessment was able to see the big picture and make connections between what they were seeing in the cases to the overall safety strategy, and the evolving safety profile.”
- VP Clinical Operations
“Our medical monitors are very impressed with MedAssessment’s clinical input. When we get narratives or reports from MedAssessment we know it’s a much higher quality. We find that MedAssessment queries are truly relevant to understanding the actual event.”
“MedAssessment is not just using templates or following SOPs instructing collection for X, Y, and Z for every case. MA goes beyond that and asks, in what way is this additional piece of information relevant to the safety story? Does this change anything, is it an update to the safety story? Should we think about coding this event differently?”
- VP Clinical Operations
A precision medicine drug sponsor with a pre-market drug candidate had, after nearly 10 years of Phase 1 and 2 studies, recently completed a Phase 3 trial. When considering the next step, a second Phase 3 trial, Senior Leadership, the Board and investors had a clear answer to the Go/No Go question: Go.
Senior Leadership, specifically the CEO, CFO and CMO, strongly preferred outsourcing to a full service CRO. However, the first Phase 3 trial, outsourced to a large, well known full service CRO, had been problematic: overall data quality had been poor, as had trial management in general.
“This is a perfect place to bring MedAssessment in to handle all safety related matters on the compound level.”
- VP Clinical Operations
Senior Leadership’s concern: it is hard if not impossible to get different CROs to play nice together in the sandbox.
“I get a lot of pressure from leadership to use a full service CRO for everything. To them, that seems like a good idea, it seems like efficiency.”
- VP Clinical Operations
While acknowledging the first Phase 3 full service CRO’s poor performance and delivery, Senior Leadership still felt very strongly that outsourcing to a full service CRO was the best, maybe even only, strategy.
“A single vendor, a single price for everything.”
“A full source CRO has all the resources, all the functional areas we could need, all under one roof.”
“All quality can be controlled and, if necessary, improved, by our vendor oversight activities."
“A single throat to choke.”
“A full service CRO only cares about the single study they manage, there is little or no historical, compound level safety data taken into account."
“Rigorous oversight of the full service CRO is required just to ensure basic deadlines are met, let alone strategic input. The need to apply additional quality measures is not uncommon.”
“The lack of program-level depth causes more problems in the long run- costs that are high, but
complex to quantify”
Solution: It took a united front, the VP of Clinical Operations, the Head of Clinical Development and the Director of Pharmacovigilance, to successfully argue for the Best of Breed approach. MedAssessment was selected as the Drug Safety Center of Excellence.
Final consensus:
“MedAssessment is the best safety strategy and operations partner we could imagine.”
“Using MedAssessment allowed us, as a pre-market small drug sponsor, to delay increasing headcount for pharmacovigilance activities.
Because of their quality impact, MedAssessment required a very light oversight footprint, unlike other providers that required significant oversight and management to ensure quality deliverables.”
- VP Clinical Operations
Headcount
Minimum of 3 FTEs: Drug Safety Physician/Medical Reviewer, Drug Safety Manager, Case Processor, Support Staff.
Technology
Safety Database: Saas Licensing, Implementation, Configuration and Validation Services, Ongoing IT Support
$3M Investment Required
$1M Investment Required
Due to the Phase 2 stage of the asset there would not be enough peak periods of work to keep the drug safety physician and others fully occupied.
Result: Assuming 50% underutilization over 3 years:
Database investment returns are fully realized only when it can be used for multiple assets, which was expected to be in or after year 5.
Result: 80% software investment underutilization in years 1-3, possibly beyond.
-$800K lost to investing in technology too early
“MedAssessment takes ownership of the entire safety function, acting as our safety department: medical assessment, drug safety strategy, case processing, and a 21 CFR Part 11 compliant safety database.”
- VP Clinical Operations
“It was big clinical program- studies being executed all over the world, many different regulatory considerations, monumental operational and data complexities. MedAssessment was able to see the big picture and make connections between what they were seeing in the cases to the overall safety strategy, and the evolving safety profile.”
- VP Clinical Operations
“Our medical monitors are very impressed with MedAssessment’s clinical input. When we get narratives or reports from MedAssessment we know it’s a much higher quality. We find that MedAssessment queries are truly relevant to understanding the actual event.”
“MedAssessment is not just using templates or following SOPs instructing collection for X, Y, and Z for every case. MA goes beyond that and asks, in what way is this additional piece of information relevant to the safety story? Does this change anything, is it an update to the safety story? Should we think about coding this event differently?”
- VP Clinical Operations
A precision medicine drug sponsor with a pre-market drug candidate had, after nearly 10 years of Phase 1 and 2 studies, recently completed a Phase 3 trial. When considering the next step, a second Phase 3 trial, Senior Leadership, the Board and investors had a clear answer to the Go/No Go question: Go.
Senior Leadership, specifically the CEO, CFO and CMO, strongly preferred outsourcing to a full service CRO. However, the first Phase 3 trial, outsourced to a large, well known full service CRO, had been problematic: overall data quality had been poor, as had trial management in general.
“I get a lot of pressure from leadership to use a full service CRO for everything. To them, that seems like a good idea, it seems like efficiency.”
- VP Clinical Operations
Senior Leadership’s concern: it is hard if not impossible to get different CROs to play nice together in the sandbox.
Senior Leadership’s concern with using different CROs: It’s hard if not impossible to get them to play nice together in the safety sandbox.
“This is a perfect place to bring MedAssessment in to handle all safety related matters on the compound level.”
- VP Clinical Operations
While acknowledging the first Phase 3 full service CRO’s poor performance and delivery, Senior Leadership still felt very strongly that outsourcing to a full service CRO was the best, maybe even only, strategy.
“A single vendor, a single price for everything.”
“A full source CRO has all the resources, all the functional areas we could need, all under one roof.”
“All quality can be controlled and, if necessary, improved, by our vendor oversight activities."
“A single throat to choke.”
“A full service CRO only cares about the single study they manage, there is little or no historical, compound level safety data taken into account."
“Rigorous oversight of the full service CRO is required just to ensure basic deadlines are met, let alone strategic input. The need to apply additional quality measures is not uncommon.”
“The lack of program-level depth causes more problems in the long run- costs that are high, but
complex to quantify”
Solution: It took a united front, the VP of Clinical Operations, the Head of Clinical Development and the Director of Pharmacovigilance, to successfully argue for the Best of Breed approach. MedAssessment was selected as the Drug Safety Center of Excellence.
Final consensus:
“MedAssessment is the best safety strategy and operations partner we could imagine.”
“Using MedAssessment allowed us, as a pre-market small drug sponsor, to delay increasing headcount for pharmacovigilance activities.
Because of their quality impact, MedAssessment required a very light oversight footprint, unlike other providers that required significant oversight and management to ensure quality deliverables.”
- VP Clinical Operations
Headcount
Minimum of 3 FTEs: Drug Safety Physician/Medical Reviewer, Drug Safety Manager, Case Processor, Support Staff.
Technology
Safety Database: Saas Licensing, Implementation, Configuration and Validation Services, Ongoing IT Support
$3M Investment Required
$1M Investment Required
Due to the Phase 2 stage of the asset there would not be enough peak periods of work to keep the drug safety physician and others fully occupied.
Result: Assuming 50% underutilization over 3 years:
Database investment returns are fully realized only when it can be used for multiple assets, which was expected to be in or after year 5.
Result: 80% software investment underutilization in years 1-3, possibly beyond.
-$800K lost to investing in technology too early
“MedAssessment takes ownership of the entire safety function, acting as our safety department: medical assessment, drug safety strategy, case processing, and a 21 CFR Part 11 compliant safety database.”
- VP Clinical Operations