info@sparkkz.com +91 8368231910

Professional Solutions

High Quality Technology Solutions with a focus on Cutting-Edge Software e.g; Reporting & Analytics (Ad-hoc, Periodic), Clinical, Regulatory and Medical Reporting solutions.

Consulting Services

Implementation, Upgradation, Migration, Configuration, Customization, Integration of Drug Safety Database etc.

IT Service Management (ITSM)

Continuous Monitoring and Improvment systems; putting an emphasis on customer demands and IT services which goes beyond conventional IT support

Quality Management

setup processes, procedures, tasks, and checklists which are neither organization-specific

About Us

Sparkz is transforming the way Life Sciences organizations develop and bring new products to market. We leverage the latest technology advancements to reduce redundancies and improve process efficiencies for Pharmaceutical, Medical Device and Biotechnology companies.

Our Services Include

  • Consulting Services
  • Managed Services
  • Computer System Validation
  • Product Development

PV Process Design and Optimization, Safety Database Selection, Implementation and Upgrades, Data Migration Planning and Execution, PV Separation / Mergers / Outsourcing, EDC Integration, Business Intelligence for Clinical and Pharmacovigilance, Quality, Compliance, and Performance Monitoring, SOP Planning, Implementation and Training, Audits and Inspection Readiness, PMO and Project Management, and Validation Services

Services

Safety System Data Migration, Implementation & Upgrade; Sparkz partners with clients – from conception to integration to deployment – for safety database implementations. We develop user requirements and conduct customer interviews for the selection of vendors. We lead PMOs for project planning and governance. We lead business process and technology work streams for the requirements definition, technical architectures, and designs. We lead validation and IT Compliance streams for validation Plans, Operational Qualification, and performance qualification. We have vast experience implementing large safety databases such as Argus and ARISg.

Consulting Services

PV Process Design and Optimization, Safety Database Selection, Implementation and Upgrades, Data Migration Planning and Execution, PV Separation / Mergers / Outsourcing, EDC Integration, Business Intelligence for Clinical and Pharmacovigilance, Quality, Compliance, and Performance Monitoring, SOP Planning, Implementation and Training, Audits and Inspection Readiness, PMO and Project Management Validation Services

Technology Solutions

Reporting and Data Analytics Solution. Document Management System. Medical Affairs System. Clinical Trial Management System

Validation and IT Compliance Services

Data Integrity Assessment, Development of remediation plans, e.g. adapting your risk-based validation strategy to new regulatory requirements, Design of software validation strategy and framework including work instructions, templates and training materials, Software Validation / IT Compliance Workshops, Development of test strategies, Development of data migration and verification strategies

Managed Services

Safety Database Configuration Management, Product and MedDRA Dictionary Management, Business Intelligence, User Maintenance, Protocol Library Maintenance, Submission Rules Maintenance, E2B Setup (Inbound and Outbound) and Service Desk L1/L2 Support

Services across the Systems

Patient Safety and Risk Management Systems, SAP/ERP Systems, Clinical R&D Systems, Regulatory Affairs Systems, Medical affairs Systems, SaMD systems, LIMS,Commercial Systems, QMS Systems,Customized Systems ( GxP and Non-GxP Systems),SNOW and Reporting Systems

Medical & Regulatory Affairs

Medical Writing, Clinical Writing, Regulatory Affairs Management and Case Processing

Next-Gen Products

Sparkz offers innovative and next generation global products that help organizations move faster, lower IT costs, and scale.

Reporting and Data Analytics

Sparkz Reporting and Analytics is the most advanced, user-friendly, and self-service tool for Regulatory Reports, Ad-hoc Reports, OOB Visualizations.Enriched with Ever Growing Standard Reports Library, Ad-hoc Reporting Capabilities with Nex Gen UI/UX. Design is not just what it looks like and feels like, Design is how it works. Strike the right balance with Sparkz Reporting and Analytics.

DocTrack

DocTrack is web-based application used to manage and track documents at one place.It is a document repository and collaboration tool.DocTrack quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision making

MedAff

Intelligent and unique platform for managing key medical Informations including reciept and acknowledgement, integration with leading Safety Systems for adverse event processing and analytical reporting.

Request a Demo

Learn more about Next generation and Innovative Products.

Team

Quantify success with a quality team.

Our delivery teams of global experts ensure accurate and timely delivery. We put quality, compliance and our customers at the centre and we are great to work with

Safety Database Migration Experts

Dedicated Technical implementation experts with decades of experience in implementing Safety Clinical database. Highly extensive experience in Safety database implementation, upgrade, migration, customization, and configurations for top pharmaceutical companies around the globe.

Technical Architects

Professional IT Architects backed with decades of experience in product design and architecture. Wide variety of exposure in creating, maintaining, and implementing IT systems and safety data base architecture and implementation

Validation Experts

Dedicated CSV and IT compliance professionals with decades of experience in validating Safety and Clinical database. Professionals who have managed IT compliance in complex enterprise projects such as SAP, Pharmacovigilance, Regulatory, Clinical R&D and QMS. Highly extensive experience in Safety database implementation, upgrade, migration, customization, and configurations for top pharmaceutical companies around the globe. Vast experience in handling IT projects roles determining business & software requirements, development, implementation and post go-live hyper care and support

Health Care Professionals

Dedicated team of HCPs with wide variety of exposure across different therapeutic areas. Our teams of HCPs are experts in Case Triaging, Sending Notifications and Case Processing. We perform Review of Case Data from Spontaneous, Health Authority, Literature, and Clinical Trial sources in the Safety Database – both for expedited and periodic reporting. We have the required experience and knowledge to submit expedited Safety Reports to Regulatory Agencies and Clinical Trial Sites

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Contact Us

Location:

Stellar IT Park, Tower2, Sector 62, Noida, Uttar Pradesh 201301

Call:

+91-8368231910

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