Meet the team
Amanda Bravery (Head of ICT, ICTU)
Amanda leads the multi-disciplinary team of Testers, Developers and Production Support staff who work collaboratively with Investigators, Trial Managers and Trial Teams to design the structure of the trial using InForm, in line with the study protocol and regulatory standards. The Inform team aims to provide Investigators and Clinical Trial Teams across Imperial College with a comprehensive service to support the collection, management and analysis of data from clinical trials.
Ayse Depsen (InForm Trainer/ Production Support Analyst)
Ayse is the ICTU InForm 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 InForm 4.6 and InForm 6.0; 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 InForm; troubleshoot any InForm access issues the user may have such as inactivated accounts and forgotten passwords as well as archiving studies when they are closed.
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 InForm 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.
Nikki O’Sullivan (eCRF Designer and Developer)
Nikki is an eCRF designer and developer within the Development team. She is responsible for designing and developing trials, liaising with trial teams to ensure the requirements of eCRFs are met. Nikki has previously worked in the InForm Test Team. This experience helps with testing the eCRFs and assisting the Test Team throughout the trial development lifecycle.
Production Support team
Nayan Das (Production Support Team Leader)
Nayan is the ICTU Production Support team leader for the InForm team. He has experience developing within the Oracle Applications Enterprise framework, after which he has successfully transitioned into the development and delivery of InForm trials. Nayan has subsequently moved into Production Support to provide user support to all InForm 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 ICTU InForm 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 InForm trials in liaison with the ICT Change team; user management; incident management and dealing with requests. His other projects entail prototyping InForm/Central Designer functionality to be used in the running of the InForm Clinical Trials 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
Margaret Osinowo (Validation and Test Team Leader)
Margaret has recently joined the team as the InForm Validation and Test Team Leader. She is an experienced test management consultant with over 12 years of experience in various areas of testing (system, functional, user acceptance and performance testing), as well as test environments such as Waterfall and Agile. She has worked across a number of industries, including manufacturing / trading, pharmaceutical companies, gaming companies, privately held companies and Auditing firms.
Over the years as a leader and Manager, Margaret has successfully provided valuable contributions towards the validation, release, quality, and resource and project management.
Adina Ion (eCRF Test Analyst)
Adina is an eCRF Test Analyst. She is predominately involved in system testing and eCRFs testing in the InForm environment. 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 ISEB qualified tester with commercial experience.
Dinesh Sivakumar (eCRF Test Analyst)
Dinesh is an eCRF Test Analyst as part of the InForm team. He is involved in system testing and development of eCRFs in the InForm environment. Having a research and life science background, he applies several approaches to testing and analysis. As an experienced member of the test team, he reviews and approves the release of trials developed across a wide range of therapeutic areas. He takes a sceptical yet risk based approach to ensure clinical trials are developed; fit for purpose and meet the regulatory demands of Good Clinical Practice (GCP). Dinesh is an ISEB qualified tester.
James Walker (Senior Validation and eCRF Tester)
James is an eCRF tester and validator and works on the various stages of validation testing, including the writing and testing of test scripts and performing user acceptance testing. He has over 20 years’ experience within the pharmaceutical industry and holds an MSc in Clinical Data Management.
Varsha Sonigra Patel (Senior Validation and eCRF Tester)
Varsha has been working with ICTU since 2011. She initially started off as a Clinical Trials Monitor for a multicentre commercial trial. In 2013, Varsha moved into the Inform team and has been working as a part-time eCRF tester/Data Manager ever since. Her eCRF testing duties predominately include system testing of eCRFs, writing and reviewing tests scripts and supporting the developers, when requested, during the designing stages of the eCRFs. She is also involved in the testing, authoring of scripts and reviewing of scripts during the User Acceptance testing stages, as well as during subsequent upgrades.
Vivienne Okona-Mensah (Senior Data Manager)
Vivienne the the team in January 2018 as a Senior Data Manager. Currently her role is to identify and implement the data management processes required with the department, working closely with the Clinical Operations team, Statisticians and InForm Team Leads. She is an experienced clinical data management professional with over 17 years’ experience working in the Pharmaceutical Industry and the Health Sector. She has extensive experience working on clinical studies spanning various therapeutic areas and phases with a strong background in study set-up and study conduct of trials.