WE DELIVER.
Your objectives. Your targets. Your dreams.
Clinical Research Services
We offer fast, flexible and tailored solutions to our clients with the key advantage of true cost effectiveness.
Early phase consultancy services
Seeing an increasing potential of local researchers from academia to progress their promising molecules to the clinical phase, we offer consultancy services on drug development and planning early phase clinical studies in the Czech Republic in most expedient and effective manner.
Regulatory affairs
A thorough understanding and knowledge of local regulatory environment is crucial for successful and timely obtaining necessary approvals for study conduct. Using our long-term expertise in this field we offer
- preparation and completion of packages for Regulatory Authority and Ethics Committee submission
- application to the national Regulatory Authority and Ethics Committees
- regular contact with RA/EC throughout the study
Clinical operations
Successful execution of clinical trial means delivering planned recruitment on time and budget while keeping high quality of all services. By providing our expertise in all related activities, we contribute to a successful completion of the projects.
By taking advantage of our extended knowledge of local market and specific challenges in the particular environment we offer identification of capable, reliable experienced sites which can adhere to ICH GCP and all applicable legal requirements and achieve their commitment to subject recruitment.
We liaise with health care institutions in order to complete site contract negotiations based on sponsor-approved budget as well as tracking, oversight and execution of payments to the clinical trial sites during the study.
We provide a close monitoring of study conduct and continuous assistance to site staff members with study administration, CRF completion, Investigator Site File updating, laboratory procedures, query resolution etc. to make sure that the study is conducted, recorded and reported in accordance with the study protocol, ICH GCP and applicable regulatory requirements.
By working in close contact with the client and with all parties involved and using the long-term expertise and local knowledge we assure that the projects run within planned budget and timelines and reach the goals and milestones. Our experienced project managers
- operationally manage clinical trials in proactive and pragmatic way, complying with timelines, milestones and budget.
- lead project team and ensure proper training of the team.
- communicate to clients and provide input to feasibility, study design and budget development.
- report continuously on study progress (resources, budget and timelines).
- develop project-specific procedures and guidelines and provide input on study related documents.
Subject reimbursement – CLINPAS
We have developed a unique online platform CLINPAS for processing subject reimbursement in clinical trials. CLINPAS is tailor-made configured to each study protocol and reimbursement specifics, thus enabling an automated payment based on just a simple click by site staff confirming the milestone in the system.
Knowing in detail all practical aspects of subject reimbursement processing, we can help Sponsors, CROs and Investigators to make this process straight forward and easy.
Subjects receive their reimbursement directly on their bank account without delay and bothersome administrative steps.
Sponsors and/or CROs receive on regular basis an overview of reimbursed visits, cost projections and reimbursement budget planning.
ABOUT US
Alhena was founded in 2019 by experienced clinical research professionals who decided to put together their extensive experience and knowledge in clinical research gained over many years to build up a flexible company facing todays challenges.
Our own experience of missing an easy, efficient way how to handle subject reimbursement in clinical trials in the Czech Republic led us to focus on this niche aspect of each trial and develop a unique online system for processing subject reimbursement. This activity has the ambition to become a significant part of Alhena’s focus.
An extensive professional background on the clinical and regulatory aspects of clinical trials conducted in the Czech Republic helps us to understand as well the needs of our clients from academia and to provide support on the path from molecule discovery to the clinical trial. Once achieving the stage of clinical trial initiation, we utilize our many years’ experience in clinical trial operational management to ensure a smooth and proper conduct of the study.
Alhena puts special emphasis on quality leading to the excellent, flexible, cost effective services and delivery of consistent and reliable results in a timely manner. All services we provide are fully compliant with international and local legal requirements and guidelines.
By delivering top quality services we build up
a long-term relationship with our clients based on reliance
and commitment to the entrusted projects.
Eva Kráčmarová, MD
Clinical Operations Director
Eva started her carrier in clinical research in 1996. She received her doctorate in medicine from the Charles University Prague. Prior to joining clinical research business, Eva practiced ophthalmology. Since her start in clinical research, Eva held various positions of increasing responsibility – Clinical Research Associate, Project Manager, Head of Clinical Research- and gained extensive experience in planning and execution of clinical trials phases I-IV in many therapeutic areas. In 2008, Eva became co-founder of successful local CRO MKS Research. After acquiring MKS Research by Central European CRO Optimapharm in 2017, Eva held a position of Country Manager at Optimapharm Czech Republic.
Eva became co-founder of Alhena in 2019.
Veronika Šebková, PhD
Business Administration Director
Veronika has nearly 20 years’ experience in the field of clinical research. She received her doctorate in biochemistry and molecular biology from the Institute of Biochemistry and Microbiology in Prague. Veronika started her carrier in the pharmaceutical industry as a research advisor and project manager of preclinical trials, then moving to clinical research with human drugs and gained extensive leadership experience in monitoring and management of clinical trials phase I-IV. In 2008, Veronika co-founded MKS Research, a local CRO company which was in 2017 acquired by Central European CRO Optimapharm. Within Optimapharm, Veronika held a position of Clinical Project Management Director. In 2019, Veronika became co-founder of Alhena.
CONTACT
Office address:
Alhena, s.r.o.
Braškovská 248/10
161 00 Praha 6
Czech Republic
+420 775 735 270
+420 607 552 024
+420 607 552 024