Pivotal
Patient recruitment, clinical development services and clinical monitoring.
What they do
From their website
Project management
Patient journey recruitment retention
- Patient profiling (opens in a new tab)
- Site and country assessment (opens in a new tab)
- Patient-centered ICF and protocols (opens in a new tab)
- Awareness campaigns (opens in a new tab)
- Study websites (opens in a new tab)
- Digital recruitment (opens in a new tab)
- Study facing material (opens in a new tab)
- DCT strategies (opens in a new tab)
Medical services
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Pharmacovigilance
Data science
- Database design and validation (opens in a new tab)
- Randomization and trial supply (opens in a new tab)
- Data transfers (opens in a new tab)
- Medical coding (opens in a new tab)
- Query programming and validation (opens in a new tab)
- Central monitoring (opens in a new tab)
- Database lock and archiving (opens in a new tab)
- CDASH standards (opens in a new tab)
- Clinical data science (opens in a new tab)
Biostatistics
Quality assurance compliance
- System audits (opens in a new tab)
- Clinical site audits (opens in a new tab)
- Trial master file audits (opens in a new tab)
- Protocol and ICF audits (opens in a new tab)
- Clinical database audits (opens in a new tab)
- Laboratory audits (opens in a new tab)
- Regulatory inspection preparation (opens in a new tab)
Study start up regulatory
- IMPDs (opens in a new tab)
- Study initiation (opens in a new tab)
- Clinical trial applications (opens in a new tab)
- Ethics Committee submissions (opens in a new tab)
- Competent Authority submissions (opens in a new tab)
- Clinical trial agreements (opens in a new tab)
- IMP labels (opens in a new tab)
- Import and export licenses (opens in a new tab)
- EU legal representations (opens in a new tab)
- Translations (opens in a new tab)
- Patient insurance (opens in a new tab)
Decentralized clinical trials dct services
- Digital recruitment and e-Consent (opens in a new tab)
- ECOA/ePRO (opens in a new tab)
- Patient Services (opens in a new tab)
- Telehealth (opens in a new tab)
- Home nursing (opens in a new tab)
- Concierge Services (opens in a new tab)
- Wearable devices (opens in a new tab)
- Telehealth platforms (opens in a new tab)
Pivotal has achieved full accreditation for the zelta formerly merative clinical development clinical trials platform
Project management
Danah
- Central Statistical Monitoring (opens in a new tab)
- Machine learning classifier (opens in a new tab)
- Statistical tests (opens in a new tab)
- AI document classification (opens in a new tab)
- Danah platform (opens in a new tab)
- AI-powered eTMF (opens in a new tab)
- Danah e-CTMS (opens in a new tab)
- Training certificates (opens in a new tab)