2. About us
We at MedWize design solutions for the life sciences industry to accelerate
Drug Development process by reducing costs to the company. Our services in
technology, outsourcing and consulting ensure process excellence with focus
on healthcare.
We collaborate with leading biopharmaceutical, CROs, and technology
companies with solutions and services that improves client success ratio. We
partner with you, by bringing industry recognized depth of expertise and
breadth of perspective to shape better ideas in developing and delivering
innovative solutions.
Our services include Clinical Operations, Clinical Data Management,
Regulatory Affairs, Medical Writing, and Pharmacovigilance, Training,
Consulting, Technology transition.
Our Vision
Our Vision is to provide industry-leading
platform for clinical R&D using innovative
technology and data analytics in
transforming clinical development today.
We pursue to enhance, enrich and
encourage newer innovations, path-
breaking discoveries and effective solutions
in the industry by offering a vibrant global
platform.Our solutions are delivered using
Infrastructure-as-a-Service (IaaS),Platform-
as-a-Service (PaaS), and Software-as-a-
Service (SaaS) with a methodology of ‘pay
as you use’ approach to clinical trials.
Our Mission
Our Mission is to work with biopharmaceutical and
life sciences companies by providing services and
solutions that will improve their success
probabilities. We strive to help them conduct their
clinical trials with less risk, faster and with lower
costs, so that better treatments reach the market
at a faster pace. Our comprehensive services
provide the expertise and capabilities necessary at
each stage of clinical trial conduct.
OurCulture
Our people make our company the way it is. We believe in enabling people
with their own space. We strive to maintain the open culture where everyone
is a hands-on contributor and feels comfortable sharing ideas and opinions.
3. OurServices
Our comprehensive services provide the expertise and capabilities as well as
the analytical expertise necessary at each stage of clinical trial development.
Clinical solutions and services include Project Management and Clinical
Monitoring functions for conducting multi-site trials. Our Data Management,
Biostatistics, Medical Writing, Safety and Pharmacovigilance, Early Clinical
Development (Phase I), and strategic planning and design services enable us
to provide end-to-end solutions to our customers.
Clinical Operations
Our strategy and expertise will helps in resolving
challenges at every stage of the drug development
process. We enable partnership with sponsors, research
sites, and patients to minimize risks. We offer:
Clinical Project Management
Clinical Trial and Site Management
Clinical Trial Monitoring
Medical Monitoring
Patient Recruitment
Contract Management & Investigator Reimbursement
Data Management
We are committed to customize data management solutions for
accuracy and reproducibility. Transparency, integrity and efficiency
from plan to database lock are our data management principles.
We offer:
CRF Design
Database Design & Programming
Data Entry & Review
Query Management & Resolution
Medical Coding
SAE Reconciliation
Database Lock
Archival
4. Medical Writing
Medical writing is an integral part of drug development process. Accurate documentation is both regulatory
demand and industry challenge. Our medical writing services support your product development to ensure
market success of your products. We offer:
Clinical study reports and Study Protocols.
CSR Synopses for public disclosure
Common Technical Document (CTD)
Summaries and overviews for EU or US Regulatory Authorities
Investigator Brochures and Patient Brochures
Patient safety narratives and Periodic Safety Update Reports
Standard Operating Procedures (SOPs)
Manuscripts Editorial support Journal/conference submission. Conference materials.
Product website content (for both scientific and patient audiences).
Educational material for patients, healthcare professionals and pharmaceutical industry personnel.
Medical marketing reviews.
Regulatory Affairs
Our Regulatory Affairs support services are comprehensive and market
specific. We help our clients to comply with changing regulatory requirements
and manage regulatory service from inception to market. We offer:
Submission management
Regulatory dossier compilation, publishing and dispatch
Investigational filings
Market authorization
Labelling Services
Post-approval lifecycle management
Regulatory Information Management System
Safety
Improving safety by providing complete and integrated safety services
throughout the product life cycle is our expertise. We offer customized
solutions to our clients and are efficient in managing both individual
activities and end to end pharmacovigilance system. We offer:
Individual Case Safety Report Management
Periodic Reports Management
Signal Detection & Management
Risk Management Plan
Literature Excellence
Safety System Configuration
Electronic Submissions setup
5. Consulting
Consulting provides strategy and management consulting services based on
life science expertise and advanced analytics, as well as regulatory and
compliance consulting services.
Learning and Development
Learning and development helps to increase the strength of the organization
by developing passionate thinkers by using the blended learning techniques
to enhance customer experience. We strive to develop and provide high
performance workforce. We offer:
Life Cycle Safety
Quality Management
Technology
Skill Soft Trainings and Personality Development
Leadership Skills and Project Management
Quality & Compliance
Assessment And Advisory Services and Enterprise Risk Management
Process Re-Engineering & Consulting
Audit Preparedness
Auditing
Our auditing service has developed a process oriented approach which is
greatly influenced by actual regulatory (MHRA & FDA) inspection experience.
We offer complete range of clinical development audits with recommended
CAPAs & Audit Certificate. We also offer QA system for PV activities. We
offer:
Affiliate Country Office
System Audit & Vendor Audit
Co-Marketing Partner Audit
Master Quality Plan and Risk based Internal Audit Strategy
Facilitate MAH for Inspection Readiness & assistance in preparing
MAH's responses to Inspection findings
Quality Management System
Technology based Management of Audits, Inspection & CAPAs
Contact us at:
Bangalore Office: ATHREYA, 1’A’ main road, Gruhalakshmi Layout, NG Halli,
Bangalore – 5600073.Karnataka, INDIA. Contact no: +91-9900095824.
Email: support@medwizesolutions.com
