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Data Management

Experience

150+

Studies

80+

Indication

45000+

Patients

120+

Code Angelo Projects

50+

Regulatory Submissions

Expertise

Robust IT infrastructure ensures your data security, privacy & uninterrupted services

Rich experience of working with industry renowned CDM systems

High quality data, on time delivery,

Efficient and tested processes with detailed documentation including SOPs, working procedures & study specific documents to comply with ICH standards, national regulations & guidelines

Stringent quality procedures including senior review (QC) & independent QA at various stages of documentation & data processing

Highly skilled talent pool, who have worked on Phase I-IV trials for a variety of therapeutic areas including Biologics and Biosimilars

Complete Clinical Data Management services from CRF Design , Deploying the database, Query generation to Database Lock (DBL) for both eCRF & Paper studies

Therapeutic Experience

Cardiac

Gastroenterology

Infections and infestations

Dermatology

Haematology

Endocrine and Metabolism

Hepatobiliary

Nervous system

Immune system

Musculoskeletal and connective tissue

Oncology

Ophthalmic

Respiratory

Psychiaty

Renal and urinary

Vaccine

Rheumatology

Reproductive system and breast

Injury, poisoning and procedural complications

Rich experience in every phase of Data Management

START-UP PHASE
  • Case Report Form Designing (pCRF / eCRF)
  • Data Management Plan Development
  • Edit check specifications
  • External Data Agreement plan (e.g. Lab, ECG, Device data etc)
  • Data Management Project Management
  • CRF Completion Guideline
  • Database Design Specification
  • Annotated CRF (aCRF)
  • Database Designing
  • Database Programming
  • User Acceptance Testing (UAT)
  • Database Live
CONDUCT PHASE
  • CDISC-CDASH / SDTM compliant data collection and processing
  • Electronic Data Capture in EDC studies
  • Double Data Entry in Paper studies
  • Discrepancy Management (System/ Manual)
  • Self-Evident Corrections
  • Tracking & Closing Queries
  • SAE data reconciliation
  • External data reconciliation and cleaning e.g. Lab, Device Data etc.
  • SAS system based data review
  • Lab normal management
  • Medical Coding using MedDRA and WHODrug Global
  • Data Export and Transfer
  • Standard report for project management
  • Ad-Hoc report
CLOSE-OUT PHASE
  • Database quality audit
  • Independent review for each document
  • Quality Control on all data processing steps
  • Quality Assurance
  • Database soft lock/ hard Lock/ Interim lock

CDM tools

Data management team have experience of working on various CDM tools

CodeAngelo ® - Cliantha’s Proprietary Tool

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CodeAngelo ®

Cliantha's proprietary Clinical Data Management platform: CodeAngeloTM - 21 CFR part 11 compliant system Diversified Features

  • Instant Validation
  • Role based secure access
  • Dynamic data entry & review workflow
  • Mid study changes Manage amendments and any mid study change instantly.
  • Standard, Ad-Hoc Reports & Role based Dashboard
  • Integrated Query Management
  • Medical coding Interface - Auto & Manual with MedDRA, WHODrug Global
  • Rapid CRF design
  • Local lab management Effectively manage local and normal lab ranges
  • Complete Reporting More then 30 reports are available along with ad-hoc query based report
  • 24x7x365 Helpdesk Support

Differentiating Primers

Advanced Performance Reporting, and Analytics for Senior Management
Flexible licensing and SAAS (Software as a Service)
Intensive Back up Solution
Highest Level of Security, Reliability & Scalability

Let’s Talk

Phone
+91 79661 35601
Address
17, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway, Bodakdev,
Ahmedabad - 380054.
Email
info@solvius.com