Amanda Bravery (Head of ICT, ICTU)

Amanda BraveryAs Head of ICT, ICTU, Amanda Bravery 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.


Training


Ayse Depsen (EDC Trainer/ Production Support Analyst)

Ayse is the ICTU EDC Trainer and Production Support Analyst. Her role is to co-ordinate online training and to provide face-to-face training to all internal and external users for the EDC systems; to maintain the training records & documents and to issue all users who have completed the training with their certificates.

Additionally, Ayse is responsible for creating user profiles in the EDC systems; troubleshoot any access issues the user may have such as inactivated accounts and forgotten passwords as well as archiving studies when they are closed.


Development team


The Development Team consists of eCRF Designer/ Developers who use customers’ requirements to design, develop, test and document eCRFs for a wide variety of trials and therapeutic areas. In addition, the Development Team is responsible for writing validation rules and liaising with the testing team through the various testing and user acceptance cycles.

Abinithya Udayakumaran (Development Team Leader)

Abi is the Development Team Leader 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 Development Team Leader, she is responsible for the leadership and management of the 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 (eCRF Designer and Developer)

Smita is an eCRF designer and developer. She is responsible for designing, developing, unit testing, documentation and other validations required for eCRFs.  Smita is also responsible for writing validation rules and guiding the testing team during various stages of the testing of clinical trials.

Zala Noorzad (eCRF Designer and Developer)

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 (Production Support Team Leader)

Nayan is the ICTU Production Support team leader 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 Production Support 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.

Kayode Disu (Senior Production Support Analyst)

Kayode is the Senior Production Support Specialist. His role is mainly service based and covers a wide range 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. His other projects entail prototyping EDC functionality to be used in the running of the Clinical Trial Portfolios supported by the team. Kayode is qualified in ITIL version 2 and 3, which is a set of practices used globally for service management.


Validation and Test team


Francesco Lala (Deputy Head of Clinical Data Systems, Validation and Test Team Leader)

Francesco has over ten 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 last 2 years his focus has been on validating computerised systems for GCP use and implementing tools for quality data collection.

Adina Ion (Validation/ eCRF Test Analyst)

Adina is an eCRF Test Analyst. She 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.

Dinesh Sivakumar (Senior Validation/eCRF Test Analyst)
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 Validation/eCRF Test Analyst, 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.

Tolulope Sokunle (Validation/ eCRF Test Analyst)

Tolulope is a validation and system test analyst with years of experiences 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 


Vivienne Okona-Mensah (Senior Data Manager)

Vivienne is the ICTU Senior Data Manager. Her 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.