Biotech Biz 

Build a credible operating model for your study

• Operational strategy & planning

• Protocol design & operational input

• Study delivery model design

• Budget, resourcing & constraint assessment

• Timeline, forecasting & dependency planning

• Milestone and change management

• ​​Start-up & activation strategy

• Country and site planning

• Recruitment and retention planning

• Monitoring & Safety Review Board set-up

• AI supported decision-making

Identify what could affect delivery before it becomes an issue 

• Quality by Design assessment

• RBQM strategy & implementation

• Inspection readiness

• Contingency planning

• ​Study start-up & recruitment risk

• Critical path, dependency and milestone risk

• Operational risk identification and prioritisation

• Data and database-readiness assessment

• Supply and vendor continuity

• Protocol deviation trends & tracking

• Monitoring and oversight signals

• Risk indicator, dashboard & escalation design

Strengthen sponsor oversight & accountability  

• CRO/vendor due diligence, qualification & selection

• SOW & budget review 

• CRO & vendor governance 

• Risk-based vendor oversight planning

• Sponsor–CRO/vendor alignment

• KPI definition, dashboards & trend analysis

• Communication & escalation pathways

• Multi-vendor coordination

• Vendor risk and issue management

• Vendor system specifications & UAT support

• Out-of-hours oversight for sponsors 

Independent visibility, reviewed at the pace each area demands

• Strategy & delivery assumptions

• Start-up & recruitment performance 

• Milestone, dependencies & bottlenecks

• CRO & vendor delivery & governance 

• Risk & quality signal monitoring

• Data-readiness tracking

• Budget and timeline exposure 

• Decision-making, ownership & escalation review

• Recovery & intervention options

• Governance and Board reporting readiness

• Dashboard & reporting accuracy

• Early warning before issues become costly