Insights into Data Integrity in the Age of Digitalization
Date: June 15, 2019
Radisson Hyderabad Hitec City
Gachibowli, Next The Platina Building,
On the way of Gachibowli to Kondpur Road,
Hyderabad, Telangana, 500032, India.
Data Integrity is one of the most important areas of consideration for clinical development these days where use of technology support is being increasingly adopted. FDA investigators continue to cite a significant number of data integrity observations during inspection. There has been an increase in regulators taking action against data fraud or false information. They are keeping pressure on those with data integrity shortcomings, issuing a growing number of warning letters and FDA-483s every year for the last few years. The analysis below shows that the data integrity findings (largely cGMP) from FDA has increased from just 4 instances in 2004 to 56 in 2017 which is around 37% of the total number of data integrity findings in 10 years across the globe.
(*)Courtesy: Barbara Unger, Unger Consulting Inc.
Even if these findings are largely with cGMP aspects currently, the concepts of data integrity remains the same and a shift of focus to GCP in the future is imminent with the digital change and data protection policy changes across the world impacting the clinical development space. With a great change in the digital landscape globally, it would be ideal for the Clinical Data Management Community to discuss and understand more about the opportunities and challenges of fundamental Data integrity principles being implemented in the new digital world of affairs.
Consulting Practice Director
Bhaskar Nellipudi is an engineering graduate and a software professional having 20+ years of IT experience in design and develop products and services delivery majorly in Health Sciences Domain. He is currently working with health sciences GBU, Oracle India as Consulting Practice Director manages Life Sciences consulting practice for APAC region. In this role, Bhaskar looks after the customers from APAC region on guiding them on how HSGBU products helps them to achieve their business goals.
Recently he involved in mHealth(digital trials) initiative to create a new offering that enables real world data using smart phones and mobile apps transfer into EDC systems and available for Investigators and Pharma Cos.
Founder & CEO
QMATRA Services LLP
Founder & CEO for QMATRA Services LLP, which is an independent Quality Assurance consulting firm.
Well versed with international and national regulatory requirements for Global Clinical Trials. Has hosted US FDA, EMEA and other regulatory inspections.
Has extensive experience in the conduct of audits: process audits, Investigator Site, Pharmacovigilance, Data Management, Computer System Validations and vendor audits across different geographies globally.
Prior to founding the QMATRA, she worked for a global CRO in India and was responsible for establishing a successful QA function and headed that function for more than a decade.
Group Head of Clinical Database Delivery, Reporting & Analytics
A.V.Prabhakar has more than 22 years of working experience in Pharmaceutical & CRO industry. Prior to joining Novartis, he worked at Torrent, Lambda & Quintiles within Statistics & Clinical Data Management functions. He also attended 3-TP Middle Management Development Programme at IIMA & Leadership Workshop at IIMB. He is an active member of SCDM India Steering Committee & till date has actively participated in various SCDM India & Annual Conference in various capacities of Speaker, Programme Chair & Session Chair. In addition, he has published more than 15 articles in various international journals & magazines of which five articles related to CDM were published in Data Basics, which is the magazine of Society of Clinical Data Management.
VP and Global Head of DM
With more than 14 years of experience in Clinical Data Management with large and small CROs, Deepu Joseph has successfully led small and large teams within Data Management globally to deliver on various therapeutic areas and phases of clinical trials for top 10 Global Pharma clinical development requirements. Has end to end data management exposure and understanding from Paper studies to various EDCs and has been successful in Capability Development and DM Offshoring, Functional Service Management, Operations Management and Optimization with strong metrics oriented strategies to meet Quality and Timeline requirements.
Director, Data Management (India & South Africa)
Sebastian has over 22 years of varied Industry experience, including over 18 years in Healthcare Industry. He has extensive leadership experience working with large FSP, Pharma and CRO Organizations and has played major role in building up Data Operations units in these organizations. Sebastian currently develops and leads organizational strategies as part of India Leadership team. He is passionate about developing people in their skillsets and professional behaviours and developing future leaders. Sebastian drives innovation and operational efficiencies through Operational Excellence.