Lumis International –
your clinical gateway to Europe
Legal representation
Lumis International was founded in 2013 with the goal to offer legal representation for non-European biopharmaceutical and medical device companies when conducting clinical trials in Europe without having a local presence. As required by the EU Clinical Trials Regulation 536/2014 Art. 74 and the former EU Clinical Trial Directive 2001/20/EC Art. 19 (1) each clinical trial needs to have a legal representative.
The customers of Lumis are organisations at all different sizes ranging from small virtual clinical stage start-up companies to publicly traded late stage clinical trial companies from all over the globe.
Lumis, having itself an SME (small-medium enterprise) Status with the European Medicines Agency (EMA), can act as your agent to obtain the SME status if eligible.
Data Representation
With the implementation of the General Data Protection Regulation (GDPR) 2016/679, Lumis offers the services as Data Representative according to Article 27 of the guideline.
Management Board
Team
Andrés Aguilar Caro
Senior Proposal and Contract Manager
Andrés Aguilar Caro has over 15 years of experience in managerial positions in operational and financial departments in the HealthCare industry. His experience is extensive as project coordinator and key leader on the implementation of integrations, as well as a contract manager. During the last years as head of proposals on clinical trial services, he has been involved as a budgeting builder and part of the negotiation Team in SaaS companies, medium and large CROs (Contract Research Organisations), building strong relationships with internal and external stakeholders along the duration of the studies. He is knowledgeable in the implications of the legal representation of companies that carry out the development of drugs in the European Union, UK and Switzerland.
Andrés carefully analyses our clients’ Request for Proposal (RFP) and provides tailored solutions to meet their needs and budgets. He is dedicated to building and maintaining strong customer relationships.
Imen Jelassi
Business Development Consultant
Imen Jelassi is a Business Development (BD) professional with over 15 years experience in the Life Sciences industry supporting service companies with their sales and BD activities worldwide.
Imen has a degree in Pharmacy and a degree in Health Marketing. She has held both scientific and sales positions which have given her a good understanding of her client’s services, added value and targeting the right prospects. Imen has great expertise in BD for different services in R&D and clinical research in a variety of therapeutic areas, with a strong focus on oncology and CNS.
Imen helps companies to showcase their services, establish valuable partnerships with pharma, biotech and medical device companies and supports her clients growth plans.
Gabriele Faist
Consultant Clinical Oversight Services
Gabriele Faist has more than 28 years pharmaceutical industry experience with 25 years working in CROs. At the CRO she was responsible for overseeing clinical drug development programs which included line management of a group of more than 20 Project Leader, Senior Project Leader and Project Assistants as well as project related leadership of worldwide multi-functional teams to effectively implement projects; tracking the progress of programs to ensure that they are being completed on time and within budget; and ensuring the quality of all work within the programs.
Razia Imran
Business Development India
Razia Fatima Imran is a Business Development professional with over 15 years in the Life Sciences industry. She supports Lumis’ Business development activities in India and USA.
Her expertise ranges from promoting Sales in the Pharmaceutical and Clinical Research Organizations sector to mediating negotiations overseas and onshore.
She works as an independent consultant for Healthcare companies by outsourcing & partnering with Indian customers & counterparts.