Conscio offers a comprehensive portfolio of early-phase clinical trial services, underpinned by decades of expertise and integrated departmental cooperation. Our two fully equipped clinical units in the Czech Republic have a combined capacity of 96 beds and deliver high-quality, regulatory-compliant studies tailored to sponsor requirements.
All activities are conducted in full accordance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), under the continuous supervision of our internal Quality Assurance (QA) unit.
Our clinical units specialise in early-phase studies with a focus on bioequivalence (BE) and pharmacokinetic (PK) research. In-house synergies and strong interdepartmental collaboration enable efficient and reliable trial delivery from planning to completion.
Clinical expertise is supported by advanced analytical tools and biostatistical capabilities, ensuring that each stage — from regulatory submissions to study reporting — meets international standards. We work closely with the Bioanalytical Department for drug and metabolite quantification and with the Biostatistics Team to ensure scientific accuracy in all evaluations.
Clinical trial services at Conscio support sponsors from study design through execution. With extensive experience in regulatory processes and operational management, the team oversees all key aspects of trial conduct.
Key services include:
These clinical functions are overseen by experienced physicians and support staff committed to the safety, well-being, and compliance of each subject enrolled.
The facility is also equipped to conduct bioavailability and bioequivalence studies involving biosimilars within Phase I clinical development. While not a primary focus, these studies can be performed based on sponsor requirements and regulatory guidelines.
Every clinical study conducted at Conscio is documented and finalised in compliance with EMA and FDA requirements. The clinical team coordinates the preparation of the clinical trial report, ensuring timely and accurate presentation of study data.
This process includes:
This structured approach ensures that sponsors receive clear, regulatory-aligned documentation reflecting the complete clinical, analytical, and statistical scope of the study.
Conscio maintains a large database of healthy adult volunteers and can recruit targeted subgroups for specific study designs. The primary focus is on adult populations aged 18–65, with established partnerships with social and healthcare institutions enabling access to defined demographics.
Our subject recruitment capabilities include:
Populations with special health conditions may also be included upon sponsor request and agreement.
Each study is designed to match its objectives, target population, and timeline. The team supports sponsors in selecting the most suitable approach and offers designs tailored to regulatory and scientific requirements.
Study design options include:
Our adaptive approach allows us to execute both traditional and innovative trial models.
Quality oversight is integrated into all clinical operations. The QA/QC unit monitors activities against internal SOPs and ensures that each study complies with GCP and GLP requirements.
Key QA activities include:
Our QA team is also available to provide independent audits and ensure that all procedures meet the highest regulatory standards.
Effective clinical operations rely on close coordination between specialised teams. The Clinical Unit works in partnership with:
This integrated approach allows us to offer end-to-end solutions, accelerate timelines, and deliver results that support successful drug development.
Let’s talk. Whether you’re scaling operations or prepping for your next audit, we’ll help you take the next confident step.
