Consent Management
Structured capture of participant or HCP consent with timestamps, version history, and linkage to specific study records for audit and regulatory review.
A specialized CRM aligns recordkeeping, compliance controls, and stakeholder workflows to reduce manual handoffs and ensure consistent documentation across clinical, regulatory, and commercial functions.
Oversees trial site onboarding, documentation flows, and vendor communications. Uses the CRM to track site status, collect signed agreements, and maintain study timelines while ensuring data handling aligns with privacy policies and internal SOPs.
Coordinates field activity, HCP records, and promotional approvals. Configures CRM dashboards for reps, monitors interactions for compliance, and integrates signed agreements or speaker engagement documents into contact records.
Teams across clinical operations, commercial, and regulatory functions rely on a tailored CRM to maintain compliance and coordinate stakeholders.
Consistent recordkeeping and access controls make cross-functional collaboration auditable and reduce downstream regulatory risk.
Structured capture of participant or HCP consent with timestamps, version history, and linkage to specific study records for audit and regulatory review.
Centralized storage of agreements and study paperwork with versioning, check-in/check-out, retention policies, and immutable audit trails visible to authorized users.
Seamless integration with compliant eSignature solutions to collect legally valid signatures and preserve signature metadata alongside CRM records.
Granular permissions for study staff, commercial teams, and auditors to ensure least-privilege access and protect PHI and sensitive contract terms.
Robust REST APIs that enable integration with clinical systems, billing, CTMS, and document repositories for automated data exchange and process continuity.
Configurable reporting for compliance metrics, study milestones, and signature statuses with exportable logs for inspections and internal reviews.
| Setting Name | Configuration |
|---|---|
| Reminder Frequency | 48 hours |
| Signature Authentication Level | Multi-factor |
| Retention Period | 7 years |
| Approval Routing | Sequential |
| Audit Log Retention | Indefinite |
CRM access and eSignature functions should be verified on common devices and browsers used by field and office teams to avoid workflow interruptions.
Ensure mobile users have secure VPN or managed device controls, and validate signature capture behavior on touch screens to meet consent and audit requirements before broad deployment.
Study coordinator captures participant consent and site agreements through the CRM to centralize records and workflows.
Resulting in faster site activation and clearer regulatory evidence for monitoring and inspections.
Procurement stores vendor contracts, scopes of work, and indemnities linked to vendor profiles in the CRM.
Leading to reduced contract cycle times and demonstrable contractual control during audits and vendor reviews.
| Criteria | signNow (Recommended) | DocuSign | Adobe Sign |
|---|---|---|---|
| HIPAA Support | |||
| API Access | REST API | REST API | REST API |
| Bulk Send | |||
| CRM Integrations | Native Salesforce | Native Salesforce | Native Salesforce |
| Plan/Feature | signNow (Recommended) | DocuSign | Adobe Sign | OneSpan Sign | Dropbox Sign |
|---|---|---|---|---|---|
| Entry-level price | Starts at $8/user/month | Starts at $10/user/month | Starts at $9.99/user/month | Quote-based pricing | Starts at $15/user/month |
| API included | Yes, included | Yes, available | Yes, available | Yes, enterprise | Yes, available |
| HIPAA-compliant option | Available | Available | Available | Available | Available |
| Free trial available | Yes, trial | Yes, trial | Yes, trial | Contact sales | Yes, trial |
| Enterprise services | Implementation support | Implementation services | Enterprise support | Full professional services | Enterprise onboarding |