About us
We are a leading Medical Research Consulting Company specializing in comprehensive support for pharmaceutical, biotech and medical device developers. Our expertise covers the entire development lifecycle from “Lab to Bedside” encompassing complex medical project planning, clinical trial execution, and beyond. With a global network in academia and the GxP industry, we go beyond traditional Randomized Clinical Trials, extending into Real-World Evidence, Health Economics, and Market Access to support a diverse range of clients.
Headoffice
339 Trida Dukelskych Hrdinu
36251 Jachymov, Czech Republic
Phone: 00420 602 100 126
E-Mail: info@lanova.eu
Data-box: zx5gx2t
Management board
- CEO
- Medical Director
Departments
Drug Development
We are covering the complete Drug Development Circle (from Lab to Bedside) with our well-rehearsed co-operation partners.
The important step during the discovery phase, once a lead compound has been identified, will be the patent strategy. Here we are supporting via our patent attorney partner Hofmann Eitle.
We are offering GMP development with our CDMO Partners Aragen Life Sciences Ltd. in Hyderabad, India and Eramol Ltd. in Dublin for Europe, preclinical research and development with Aragen, filing for regulatory status, to initiate clinical trials on humans, and include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process from concept through preclinical testing in the laboratory to Phase I–III trials together with our Central Lab Vimta Labs Limited in Hyderabad and the international CRO COMAC MEDICAL including Phase I Unit in Bulgaria.
Our Partners:
Geistiges Eigentum ist seit 130 Jahren die Kernkompetenz von HOFFMANN EITLE. Wir sind eine der führenden IP-Kanzleien in Europa und an acht Standorten in fünf Ländern für Sie im Einsat
Aragen is a trusted R&D and manufacturing partner to the global life sciences industry. From concept to commercial, we transform your ideas into solutions for better health.
Eramol is perfectly positioned and proud to support your bespoke manufacturing requirements that enable better healthcare for the world. We are as passionate about your success as you are.
From the soil that sustains life to the crop that it yields, the food and food products that we consume, the water we drink, the air we breathe, the environment we are exposed to, the medicines we need, to the diagnostic tests we undertake and many more such as electronic products and components; VIMTA has been offering its robust testing, consultancy and contract research solutions impacting many aspects of life.
Comac Medical is a global full-service Contract Research Organization (CRO) and Site Management Organisation (SMO). We offer comprehensive in-house clinical trial solutions for different stages of clinical trials from Phase I to Phase IV, and clinical investigation services for medical devices and food supplements.
Medical Devises / IVDR
We are offering a full range of services, from designing and maintenance of Technical Documentation as well as Clinical Evaluation Reports (CER) to executing clinical trials and conducting PMCF surveys and reprotings. LaNova provides with its years of experienced support for medical device and IVD clinical data collection, with a practical approach and a focus on quality and compliance.
- Dedicated to medical device and IVD clinical data collection
- Medical writing and maintenance of TD and CER
- Covering all phases of clinical development, including PMCF surveys
- Strategic and regulatory compliant clinical data collection
- High quality combined with a practical approach
- Experienced team members, short communication line
Medical Information
We are providing evaluated, balanced information and advice on all clinical aspects of medicines to doctors, nurses, pharmacists and other healthcare professionals. Our Medical Team within Medical Information gives unparalleled support on very level of promotional and non-promotional material in any oncology indication by medical review, related references and literature search and approval and release process but limited to German and Austrian Medicinal Product Act.
- Creation of speaker slides
- Medical input on non-promotional and promotional material
- Literature search for non-promotional and promotional material
- Medical review of non-promotional and promotional material
- Medical approval of non-promotional and promotional material
Acting as Information Officer acc. to Medicinal Product Act (HWG) on client’s request.
Training
We offer Good Clinical Practice (GCP) and Good Pharmacovigilance Practice training and refresher courses for people supporting clinical research on small companies or universities and other publicly funded organisations, individualised to client’s specific needs. These include GCP certification and informed consent.
Our Training department serves and conducted also onboarding and refresher courses for the LaNova team and interact directly with our QA department.
Quality System
Our small Quality Management and Compliance team is involved in all aspects of the Product Lifecycle from innovation to commercialisation providing strategic consultancy related to compliance in every stage from development to product withdrawal. From early innovation, we guide our clients through all stage gates towards and beyond commercialization, consulting with them on anything that will impact the quality and compliance of the final product.
Our Quality Management Team serves and conducted also internal as well as external, even on clients’ request, audits.
They are responsible for:
- Maintaining LaNova’s Quality System
- Creating and updating new SOPs
- Direct interaction with the Training Team
- Directly involved in any ISO certification and re-accreditation
- Directly involved in any Due Diligence activities
- Planning and conducting internal and external Audits
Accounting
The LaNova accounting department focuses on recording, classifying, and reporting financial transactions. The team ensures that all financial records are accurate, up to date, and compliant with regulations. Accountants prepare financial statements, such as balance sheets and income statements, which provide a snapshot of the company’s financial health.
The team play a key role in any the financial health of the whole company. They are also involved in any Due Diligence activities.
Scientific Projects
EU funding projects
The EU provides funding for a range of projects and programmes. It applies strict rules, for tight control over how funds are used and to ensure money is spent in a transparent, accountable manner.
The EU budget is crucial for responding to the challenges the EU faces. It ensures that the EU remains democratic, peaceful, prosperous and competitive. The EU uses its budget to finance EU priorities and big projects that most EU countries could not finance on their own – either because of the project’s size or its cross-border nature. By pooling resources, standing together and helping all EU countries, their citizens and beyond, the EU budget strengthens Europe’s economy and geopolitical standing.
msGuide
msGUIDE aims to revolutionize Inflammatory bowel diseases (IBD) treatment by offering high-performance insight into local drug distribution and concentrations that can lead personalized medicine in IBD patients and early drug development through identifying specific targeted cells of drugs, elucidating the individual phenotype and thereby patient stratification.
IBD are chronic relapsing inflammatory disorders of the gastrointestinal tract affecting 2.5 Million patients in Europe alone. The majority of newly diagnosed patients are in adolescence or early adulthood and in the midst of their family life, career, and social development.
Our Values
For us within LaNova Medical social responsibility as an ethical framework in which individuals or corporations are accountable for fulfilling their civic duty and taking actions that will benefit society as a whole, has a key priority. Also, our ethical standards as a set of moral principles that govern our company’s or person’s behavior. Therefore, we had incorporate ethics into our daily actions, particularly those decisions that affect other people or the environment. Our code of social responsibility and ethical behavior which is established within our organization as well as during interactions with others outside of our company.
In 2016 we founded Nadace St. Joachim – Stiftung Sankt Joachim. For more information, please visit our foundation website.