Meet the Team
Francesco Lala (Head of Clinical Data Systems)
Francesco leads the Clinical Data Systems team; a multi-disciplinary team of Developers, Testers and Production Support staff, who work collaboratively with Investigators and Researchers to provide an electronic data capture system in line with the study protocol and regulatory standards. The team successfully supports many Imperial College Investigators and Clinical study teams with a comprehensive service to facilitate easy, fast and accurate data collection, management and analysis through electronic data systems.
Francesco has many years’ experience in Clinical Trial Research. He has worked in multi-disciplinary international clinical trials and research including setting up Phase I/II clinical trials across different countries. Over the recent years his focus has been on providing and implementing quality data capture solutions for GCP use.
Systems Development team
The Development Team consists of Data Specialists who use customers’ requirements to design, develop, test and document eCRFs for a wide variety of trials and therapeutic areas. In addition, the Systems Development Team is responsible for writing validation rules and liaising with the testing team through the various testing and user acceptance cycles.
Abinithya Udayakumaran (Systems Development Manager)
Abi is the Systems Development Manager for the CDS team. She has several years of experience within the clinical industry as trial lead/database developer and reports developer. She has knowledge in EDC (Electronic Data Capture) and eCOA (Electronic Clinical Outcome Assessment) systems. She has worked across several therapeutic area studies. As Systems Development Manager, she is responsible for the leadership and management of the Systems Development Team with the aim of delivering high quality eCRFs for healthcare related trials through the lifecycle of design, development and unit testing. She is also responsible for ensuring that the solutions delivered are both fit for purpose and compliant with regulatory requirements and delivered within strict timelines.
Smita Das (Data Specialist)
Smita is responsible for designing, developing, unit testing, documentation and other validations required for eCRFs. She is also responsible for writing validation rules and guiding the testing team during various stages of the testing of clinical trials.
Zala Noorzad (Data Specialist)
Zala is responsible for designing, developing, unit testing, documentation and other validations required for eCRFs. She has previous experience working in clinical trials, including performing site data management, operational responsibilities and designing source documents for early phase cancer trials.
Production Support team
Nayan Das (Data Systems Manager)
Nayan is the ICTU Data Systems Manager for the EDC systems. He has experience developing within the Oracle Applications Enterprise framework, after which he has successfully transitioned into the development and delivery of EDC systems. Nayan has subsequently moved into Data Systems to provide user support to all CDS study teams. Nayan's role involves investigating any reported issues and liaising with various internal/external colleagues to gain a resolution. Another key area of his role is the loading/extracting of study data. Nayan has been heavily involved in the CSV activities in these areas, in addition to the more regular validation activities associated with maintaining a production environment.
Lee Barker (Senior Data Specialist)
Lee has an extensive background in clinical trials and has a wealth of experience working with OpenClinica and INSIGHT. He will be helping the team to cover a wide range of activities, such as releasing trials to the test server for User Acceptance Testing (UAT); delivery of EDC trials in liaison with the ICT Change team; user support; incident, capacity and availability management. Other projects entail prototyping EDC functionality to be used in the running of the Clinical Trial Portfolios supported by the team.
Vanaja Kakarla (Data Specialist)
Vanaja has completed her Masters in Medical Biochemistry and has extensive experience gained from working at Imperial College London since 2009. Most recently, she focused on Clinical Trial Research and Management, relating to Infectious diseases.
Vanaja helps to deliver high quality, thoroughly tested and documented eCRFs (electronic case report forms) using EDC systems (e.g., OpenClinica v4.0) for healthcare related studies through design, development, authorship and execution of test scripts, and support to studies.
Validation and Test team
Vacancy (Deputy Head of Clinical Data Systems)
Role to be advertised in due course.
Dinesh Sivakumar (Senior Data Specialist)
Dinesh has an academic and research background and holds a PhD in General Anaesthesia research. He is also an ISTQB BCS Certified tester with several years’ experience in testing and validating electronic data capture systems used for clinical research. Dinesh provides validation support throughout the software development lifecycle and in line with relevant regulatory guidelines.
As a Senior Data Specialist, Dinesh is responsible for the validation of systems used for Good Clinical Practice and bespoke trial designs in electronic data capture systems including InForm, Oracle Health Science and OpenClinica.
Adina Ion (Data Specialist)
Adina is predominately involved in the validation and testing of electronic data capture systems used for clinical research. She authors test scripts and executes tests working closely with the validation test lead, eCRF testers, eCRF developers and senior management.
Adina has a strong background in medical technology and she is an ISTQB-BCS Certified Tester with experience in highly regulated industries.
Tolulope Sokunle (Data Specialist)
Tolulope is a Data Specialist with years of experience within the financial and IT sectors.
She is presently involved with all testing processes within CDS but deals predominantly with the validation and testing of eCRFs adopted for use in clinical trials, using InForm, oracle based software and OpenClinica.
Tolulope has a degree in mechanical engineering.
Data Management
Kenan Direk (Principal Data Manager)
Kenan leads the data management team at the ICTU. He is responsible for setting the Unit's approach to data management & ensuring all data activities are conducted to the highest standards in accordance with study/funder requirements across study phases and therapeutic areas.
Vivienne Okona-Mensah (Senior Data Manager)
Vivienne's role involves identifying, devising, and implementing data management processes required within the department, she works closely with the Clinical Operations team, Statisticians and ICTU Team Leaders.
She is a skilled clinical data management professional with a wealth of experience working on clinical trials spanning numerous therapeutic areas and phases having worked in the pharmaceutical industry and NHS/Private healthcare settings.
Safa Anwar (Data Manager)
Safa's role is a hybrid one, working as Data Manager for both the CDS and ICTU-Global teams. She is involved in all data management tasks throughout the lifetime of a trial incluing the production of relevant documents, as well as the collection, storage, preparation for evaluation, extraction and archiving of data collected.
Safa utilises her breadth of experience in bioinformatics and computing, applying these skills into a clinical environment to further a new era of clinical trials.