Capture Clinical Trial Source Data Directly at the Point of Care

Direct Source Data Entry

Site-Based Capture

21 CFR Part 11 Compliant

Replace paper source documents with structured, validated electronic capture at the site. Jeeva eSource eliminates transcription from paper to EDC, reduces query burden, and accelerates data availability across site-based and hybrid trials.

Connected eSource + EDC Workflows Across Clinical Trial Execution

Jeeva eSource enables site staff to capture source data directly in a structured electronic format at the point of care, eliminating the paper-to-EDC transcription cycle that drives queries, delays, and data inconsistencies.

The platform auto-maps source data to EDC fields, maintains a complete audit trail for every entry, and integrates with CTMS and IWRS for end-to-end operational visibility.

Clients Love Jeeva Solutions

Compliance Programs Supported 

Features

Jeeva eSource Simplifies
End-to-End Source Data Workflows

01

Protocol-Driven Visit Templates

Deploy visit-specific eSource forms built to your protocol schedule - assessments, vitals, procedures, and assessments are pre-structured for site staff.

02

Auto-Mapping to EDC Fields

Captured data flows directly to corresponding EDC case report form fields, removing manual transcription and eliminating a major source of queries.

03

Real-Time Validation at Point of Entry

Apply edit-checks and range validations at the moment data is entered — surfacing issues immediately so they can be corrected before the visit ends.

04

Electronic Investigator Sign-Off

Investigators review and sign source records with compliant electronic signatures, with time-stamped audit trails for every entry and correction.

05

Integrated Adverse
Event & ConMed Capture

Record AEs and concomitant medications with MedDRA and WHODrug coding directly within the eSource visit flow — no separate system required.

06

Centralized Audit
Trail & Data Traceability

Every data point, change, and signature is tracked in a centralized, tamper-evident log aligned with FDA and ICH inspection requirements.

eSource Integrated with EDC, CTMS, and IWRS for Unified Trial Operations

Configure visit-specific eSource forms in days, not weeks

Reflect protocol amendments across all eSource templates rapidly

Standardized form library accelerates study startup

Monitor data completeness and quality in real time from the sponsor dashboard

Support remote monitoring with transparent, timestamped source records

Adverse Events and Concomitant Medications (ConMeds)

Capture adverse events or symptoms with MedDRA data coding or controlled vocabularies.

Capture ConMeds reported by patients or site staff using the standardized terms from WHODrugDB.

Controlled vocabulary helps avoid spelling, typos, manual errors, or incomplete names.

Benefits

Real-Time Collaboration Across Clinical Trial Operations

Remove the paper-to-EDC transcription cycle that generates the majority of data queries in site-based studies.

Sponsors and monitors can review source records remotely with full audit trail visibility, reducing on-site monitoring visits.

Source data captured electronically is validated and available to sponsors in real time, reducing time to database lock.

Streamlined visit workflows let coordinators focus on patients, not paperwork, reducing administrative time per visit.

Complete, time-stamped, and version-controlled source records are available at any time for FDA, EMA, or sponsor audits.

Testimonials

Client Testimonials

In looking for a software partner, our research coordinators and investigators in the field could call the Jeeva team anytime, get reliable support, and have reassurance as we enroll patients on the go. You can count on Jeeva when time is of the essence in operationalizing a clinical trial.
Dr. Emmanuel Gorospe
Chief Medical Officer of KCRS
Jeeva is a game-changer for our rare diseases site/CRO. It is unfair to expect patients or healthy volunteers to visit a hospital or clinic when it is not necessary when a task can be effectively completed safely, remotely, and from the comfort of where they live.
Marshall Summar, MD, Ph.D
CEO, Uncommon Cures LLC
We are pleased to collaborate with Jeeva for the eCOA module for our investigator initiated observational study to understand toileting use by individuals with certain brain disorders
Dr. Terry Jo Bichell
CombinedBrain
Jeeva platform & service is aligned with our vision to making CAR-T cell therapies affordable in emerging markets.
Rahul Purwar
Founder at ImmunoACT
Jeeva gave us exactly the configurations we needed for our Pivotal clinical trials. I appreciate the functionality of the system.
Mihaela Plesa, BA, CCRP
Director, Clinical Research Programs at Frantz Viral Therapeutics

In looking for a software partner, our research coordinators and investigators in the field could call the Jeeva team anytime, get reliable support, and have reassurance as we enroll patients on the go. You can count on Jeeva when time is of the essence in operationalizing a clinical trial.

Dr. Emmanuel Gorospe

Chief Medical Officer of KCRS

Jeeva is a game-changer for our rare diseases site/CRO. It is unfair to expect patients or healthy volunteers to visit a hospital or clinic when it is not necessary when a task can be effectively completed safely, remotely, and from the comfort of where they live.

Marshall Summar, MD, Ph.D

CEO, Uncommon Cures LLC

We are pleased to collaborate with Jeeva for the eCOA module for our investigator initiated observational study to understand toileting use by individuals with certain brain disorders

Dr. Terry Jo Bichell

CombinedBrain

FAQ

Common Questions About Jeeva eSource

Ask our chat agent in the bottom right-hand corner anything about us or our solutions.

What is eSource and how is it different from EDC?

Electronic Data Capture (EDC) is the system where clinical trial data is formally recorded and managed. eSource refers to the original electronic capture of data at the point of care — eliminating paper source documents and the manual transcription step into EDC. Jeeva eSource connects directly to Jeeva EDC so data entered by site staff flows automatically into the corresponding eCRF fields.

Does eSource meet FDA 21 CFR Part 11 and ICH GCP requirements?

Yes. Jeeva eSource is built to comply with FDA 21 CFR Part 11 for electronic records and signatures, ICH E6(R2) Good Clinical Practice guidelines, and EMA regulations. Every entry is time-stamped, attributable, and audit-trailed in alignment with ALCOA+ data integrity principles.

How quickly can eSource forms be configured for a new study?

Jeeva's library of standardized eSource templates and visit configurations enables rapid study setup. Most protocols can be configured and validated within two weeks. Protocol amendments can be reflected in existing templates in hours, at no additional cost.

Can remote monitors and sponsors access source records without traveling to the site?

Yes. Sponsors and CRA monitors can access eSource records remotely through the Jeeva platform with role-appropriate permissions, supporting risk-based monitoring approaches and reducing the frequency and cost of on-site monitoring visits.

How does eSource handle adverse events and concomitant medications?

Adverse events and concomitant medications are captured within the eSource visit workflow using MedDRA and WHODrug controlled vocabulary dictionaries. This eliminates free-text entry errors and ensures data is coded consistently from the point of capture — reducing downstream coding queries.