Audit Trail
Complete, tamper-evident logs showing who did what, when, and where, including document versioning and a forensics-grade record for inspections and internal reviews.
A targeted RFP ensures vendor responses address industry rules, integration complexity, and data-security needs so decisions align with clinical and commercial obligations.
Manages user permissions, oversees data flows from clinical systems, and requires detailed audit trails and role-based access to ensure trial and post-market activities remain compliant with internal policies and external regulations.
Evaluates vendor evidence for HIPAA, ESIGN/UETA compliance, and data retention policies, and requires assurance that document provenance, signatures, and change logs meet inspection and submission standards.
Procurement, IT, regulatory affairs, commercial operations, and clinical support teams typically collaborate on the RFP document and evaluation.
A clear cross-functional review process reduces scope gaps and ensures technical and compliance acceptance criteria are enforceable.
Complete, tamper-evident logs showing who did what, when, and where, including document versioning and a forensics-grade record for inspections and internal reviews.
Granular access control mapped to job functions and study roles, enabling least-privilege assignments and separation between clinical, commercial, and vendor users.
Support for multi-factor methods and directory integration (SAML, SCIM) to ensure secure, auditable user sessions and centralized identity management.
Well-documented REST APIs, webhooks, and SDKs for Salesforce, major CRMs, clinical data platforms, and document repositories to automate data flows and reduce manual reconciliation.
Template management, field locking, enforced workflows, and retention policies that meet regulatory and corporate records management requirements.
Availability of SOC reports, penetration test summaries, and documented HIPAA and ESIGN/UETA adherence to support vendor due diligence and procurement approvals.
Two-way synchronization of contact, account, and opportunity data with triggered document generation and signature status updates to keep commercial pipelines accurate and auditable.
Native connectors to enterprise repositories like Box, SharePoint, and secure S3-compatible storage with retention controls aligned to corporate policy and regulatory timelines.
Support for sending, templating, and signing directly from Google Docs and Drive while preserving version history and audit metadata for compliance.
Secure file exchange and HL7/FHIR-compatible endpoints or middleware support to exchange clinical attachments without exposing PHI in transit or at rest.
| Setting Name | Configuration |
|---|---|
| Signature Routing Model | Sequential |
| Reminder Frequency | 48 hours |
| Maximum Signer Attempts | 3 attempts |
| Retention Policy Default | 7 years |
| Audit Log Retention | 10 years |
Ensure the RFP states required client platforms, mobile support, and browser compatibility for users in field and office environments.
Clarify expected behavior across platforms, accessibility needs, and supported OS versions so vendors can state constraints and testing coverage explicitly.
A mid-size sponsor required fine-grained role controls for study teams and vendors to limit PHI exposure
Resulting in demonstrable audit logs and faster inspection responses that met internal SOPs and regulator expectations.
A specialty pharma company sought integrated eSignature and CRM workflows for promotional contracts and speaker agreements
Leading to consistent record retention, consolidated reporting, and auditable approvals during compliance reviews.
| Feature, Technical, or Regulatory Criteria | signNow (Recommended) | DocuSign | Adobe Sign |
|---|---|---|---|
| HIPAA-compliant offering | |||
| Bulk Send support | |||
| Native Salesforce integration | Salesforce Connector | Salesforce Connector | Salesforce Connector |
| API availability and docs | Comprehensive REST API | Comprehensive REST API | Comprehensive REST API |
7 years post-study completion
10 years post-termination
7 years or per state law
10 years for traceability
Immediate suspension of deletions
| Subscription Plan or Tier Name | signNow (Recommended) | DocuSign | Adobe Sign | PandaDoc | Dropbox Sign |
|---|---|---|---|---|---|
| Starting price (per user, monthly) | $8 per user/month billed annually | $25 per user/month | $40 per user/month | $19 per user/month | $15 per user/month |
| Minimum users | 1 user | 1 user | 1 user | 1 user | 1 user |
| API access included | Included in business plans | Included in business plans | Included in business plans | Included in business plans | Included in business plans |
| HIPAA support available | Yes, BAA offered | Yes, BAA offered | Yes, BAA offered | Yes, with higher tiers | Yes, BAA offered |
| Enterprise SLA and support | Enterprise SLAs available | Enterprise SLAs available | Enterprise SLAs available | Enterprise SLAs available | Enterprise SLAs available |