Balancing compliance, collaboration, and data integrity in life sciences.
The challenge of clinical data collaboration
Pharmaceutical research depends on constant data exchange¨between sponsors, CROs, labs, and regulators. Yet every shared dataset carries enormous responsibility: it includes protected health information (PHI), intellectual property, and confidential trial outcomes. Most organizations still rely on email encryption portals or FTP uploads to share results, creating:
¤ Multiple uncontrolled copies of sensitive datasets
¤ Gaps in HIPAA, GDPR, and Part 11 compliance
¤ Delays caused by password-protected portals and manual approvals
When lives, approvals, and billion-dollar therapies are at stake, “almost secure” isn’t enough.
Why traditional methods fail
Legacy tools isolate data from your governance environment. Once a file leaves Microsoft 365, it escapes:
¤ DLP policies and sensitivity labels
¤ Audit trails required for regulator review
¤ Data residency guarantees
This leads to version drift, untracked access, and audit complexity. The result: higher compliance cost and lower research velocity.
The modern approach: in-platform, policy-based sharing
Instead of sending trial data outside your tenant, leading pharma companies now practice in-platform collaboration—keeping data where it’s governed while granting secure, temporary access to approved partners. That’s the model eSHARE enables inside Microsoft 365.
How eSHARE secures clinical trial data
eSHARE replaces risky file transfers with policy-driven secure links that honor regulatory requirements.
Key safeguards include:
➥ Data residency assurance: Files stay in your Microsoft 365 tenant and region.
➥ Native DLP enforcement: Microsoft Purview policies protect PHI and IP.
➥ Granular access controls: Limit by user, organization, or domain; add expiry dates and watermarks.
➥ Immutable audit logs: Every access and modification recorded for inspection.
➥ Zero replication: No secondary data copies in external systems.
➥ Compliant encryption: Microsoft 365 encryption in transit and at rest, meeting HIPAA and 21 CFR Part 11 standards.
Benefits for life sciences organizations
➥ Protect PHI and trial IP under a single governance framework
➥ Accelerate regulator communication with traceable, compliant sharing
➥ Reduce vendor risk by eliminating third-party data storage
➥ Enable secure multi-site collaboration for CROs and academic partners
➥ Simplify audits with unified reporting inside Microsoft 365
eSHARE turns Microsoft 365 into a compliant collaboration hub for life sciences—keeping clinical data secure, auditable, and fast-moving.
FAQ Section
1. Why is secure data sharing critical in clinical trials?
Clinical trial data includes PHI and proprietary research. Uncontrolled sharing can violate HIPAA, GDPR, or Part 11 regulations and compromise patient privacy or trial integrity.
2. What are the risks of using email or FTP for trial data?
These methods create duplicate files and untracked access. They lack unified audit logs, DLP enforcement, and data residency control.
3. How does eSHARE secure clinical trial collaboration?
eSHARE keeps all files within Microsoft 365 and enables secure link-based sharing governed by Purview DLP and sensitivity labels, ensuring full auditability and compliance.
4. Can eSHARE meet HIPAA and FDA 21 CFR Part 11 requirements?
Yes. eSHARE leverages Microsoft 365 encryption, audit logs, and access controls aligned with these frameworks.
5. How does it improve collaboration speed?
By removing external portals, eSHARE allows CROs, labs, and regulators to co-author or view data instantly—no separate accounts or downloads.
6. Does it support global data residency?
Yes. eSHARE maintains residency within your Microsoft tenant’s regional data centers, satisfying GDPR and cross-border transfer requirements.
