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, 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.
Sathya Ram
Project Assistant
Sathya Ram holds a Bachelor’s degree in German Studies from the University of Manchester. During her time at university she undertook modules in Linguistics, Translating and Cultural Studies. She spent her compulsory year abroad working as an English Teacher in Berlin.
Prior to joining Lumis International she worked as a Team Assistant for an international consultancy firm. Sathya has also gained experience in marketing, having worked in social media and as a marketing assistant for a clothing company.
Hans-Heinrich Nickell
Business Development Consultant
Hans-Heinrich has more than 20 years of experience in clinical development support for pharmaceutical companies, biotech, medical device and in the vaccine industry.
Hans-Heinrich has over 20 years of experience in Business Development in the Medical Device, CNS, Infectious Diseases, Immunotherapy, Vaccine and Oncology industry.
He has worked as a medical doctor and in the pharmaceutical industry. Our clients are guided by Hans with his high-level scientific understanding and years of expertise.
Hans-Heinrich holds a degree in Pharmacy from the Philipps University in Marburg and a degree in Human Medicine from the Albert Ludwig University Freiburg.
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.