Complete Study Rescue:
Infectious Disease International Trial Rescue at Study Midpoint
NCGS was brought in by a top tier pharmaceutical company to rescue an international pivotal infectious disease study. The study was being managed by a large publically traded CRO. To find a solution, we had to understand the issues the study, sponsor and sites were facing. NCGS formulated a plan; below summarizes the positive impact of establishing a quality team of 10 year tenured staff, the cost of not doing it right the first time and the impact on subsequent sales:
- Study Pain points - DCFs, CRA turnover, CRA experience, payment promptness, grant funding
- Feet on the street for discovery -
- Our industry is handheld and human-driven requiring delivery of human-to-human credible commitments
- Our industry is handheld and human-driven requiring delivery of human-to-human credible commitments
- $24 Million Complete Rescue -
- Shifted 80/20 rule to 80/30, increased targeted enrollment and evaluability
- 13 previously inactive sites enrolled 77 subjects
- 85% sites enrolling
- 36% increase in targeted population enrollment
- 26% increase in evaluability (from < 40% to > 66% in critical care indication)
- Outcome: Positive study results presented at IDSA, labeling changes underway, formularies already shifting
- Closed enrollment two months early
- Successful fiscal return ($1.15B annual sales = ~ $192M in two months)
- Successful fiscal return ($1.15B annual sales = ~ $192M in two months)
- Real Cost of Not Doing it Right The First Time
- DCF range shifted 80% - From 75-100 DCF per subject to 8-28 DCFs per subject = Fiscal impact $300k
- DCF Patterns defined and retraining corrected repeat patterns
- Global study extension = Increased development costs
- Damaged relationship with customer base and reticence to conduct future Sponsor trials
- Delayed time to market / reduced marketable period of patent lifetime = Lost revenue
- Successful fiscal return ($1.15B annual sales = ~ $192M in two months)
- Successful fiscal return ($1.15B annual sales = ~ $192M in two months)
- DCF range shifted 80% - From 75-100 DCF per subject to 8-28 DCFs per subject = Fiscal impact $300k
- Fiscal Development Savings - $10,746,989.00
- $700,000 ($350,00/mo.) saved by not having trial open x2 additional months
- $300,000 saved by effecting a data quality shift / dramatic DCF drop
- $3,642,500 saved in avoiding additional Subject Monitoring by positively shifting evaluability
- 775 x $3,500 visit + $1,200 travel
- $6,054489 saved in site grant funds
- Evaluability Shift from 40% to 65% dropped the overall enrollment requirement
- 775 Additional Subject Enrollment avoided due to evaluability shift
- MRSA 339 X $5,000 = $1,695,510
- Non MRSA 436 x $10,000 = $4,358,979