Embedded Files
Your NxtGen KEE to
Medical and Clinical Research
Advisory, Consulting & Solutions
Strengths
KEE* to higher standards of Commercial and Academic Research projects in the field of medicine and allied public health
30+ years of *Knowledge, Experience, and Expertise (KEE) in implementation and building of R&D business in bio-pharmaceuticals
Strong Local and Global exposure
Novel concepts devised from extensive global experience and compliance standards
Vast and varied exposure to cross-cultural work environs
Values
Our values are to support and guide industry into maintaining :
High Integrity standards
Compliance with local and global research standards
Objective measures to help find unbiased solutions based on risk identification, assessment, and review methodology
Monitoring and maintaining quality, using objectivity
Transparency and pin-pointed responsibility mapping (RACI)
Plan, Do, Control, Act implementation for continuous quality improvement (PDCA cycle)
Upholding high-quality deliverable culture
Services
Advisory Role - for Senior management-level consulting and Advisory roles related to clinical or health projects (commercial or academic)
Business Startup - Set-up Clinical Research, or Bio-pharmaceuticals or Medical Devices organizations
Project Management - Phase 1, 2, 3a, 3b, 4 studies (local or global)
Clinical Operations - Phase 1, 2, 3a, 3b, 4 studies (local or global)
Quality Reviews - Site selection, Monitoring, Auditing, Regulatory Inspection support, Setting up IQRMP process
Process Reviews - Setup and write SOPs, Review processes & systems, SOP Process Teams, SOP revisions and improvements, Dashboarding for performance, quality and risks
Green-field Setups: Setting up Centralized Monitoring, Remote monitoring and KRIs/KRI/KQIs and QTLs from ground zero
Regulatory & Medical Writing - support in compilation and submission of research related regulatory applications, liaison with the regulatory agency, updated regulatory training for project teams, publications, clinical study reports (CSR)
Training & Workshops - Ethics committees, Site project teams, Investigator Meetings, Sponsor project Teams, Clinical Research Service organizations (CROs), Site Management organizations (SMOs), Academic & NGO research teams
Methodology training :
Quality: Root Cause Analysis, Process scorecard, QbD, QMS set up and maintenance
Project Management: CTMS, Project Finance, Agreements
SOP writing & Workflow designs
Clinical Operations over-sight
Risk-based proactive approach using intelligent data- driven decisions (PRO-Active id3) and business analytics, ICH-E6 (R3)
Consulting - short or long term assignments covering the above areas
Technology Adoption & Change management - Assist in training staff on the adoption of technology platforms and help in change management, help in conceptualization, and setting up business analytics from different platforms using your current SOPs and WFs.
Data Management - Collaboration with modern tech eCRF, IWRS, Rx supply mgmt, CTMS & business analytics company for best technology
CONTACT
Dr. Gopalkrishna Pai, Ph.D., DBM
Founder & Proprietor,
Pi Clinical Research Consultants (GSTIN: 29AAEPP6642D1ZM)
Bangalore, INDIA
Phone: +91 98861 69223
e-mail: paigop@pi-crc.co.in
Page updated
Report abuse