Cardiomedex

PhysioStim is recognized as one of Europe’s most reliable CROs specializing in cardiovascular safety pharmacology. Our experts offer electrophysiological studies and preclinical resources as well as their dedicated expertise in answering ICH S7A and S7B guidelines in accordance with GLP. We also respect the 3R principle and have already taken steps to comply with the upcoming CIPA guideline.

PhysioStim has a history in excellence. Ever since our creation in 2000, PhysioStim has grown into a highly valued team that rises to the challenge of designing and conducting high quality studies for drug development. Our scientists are recognized for their expertise, reactivity, motivation and awarded with the loyalty of a consistently growing customer base.

We recently teamed up with ApconiX to create a European Centre of Excellence for Nonclinical Cardiac Electrophysiology. The PhysioStim-ApconiX alliance is designed to help companies make better decisions when it comes to selecting the optimal clinical lead candidate at an early stage. Both PhysioStim and ApconiX combine their extensive expertise in cardiotoxicity to offer a complete range of preclinical cardiac safety studies, ranging from screening to customized problem-solving studies to offer an integrated solution, from in vitro to in vivo models. One-to-one customer relations are key to our business. This new alliance will not change the way we work. You’ll still have a single contact person to guide your ongoing and upcoming projects and help you determine the best solution to evaluate your drug candidate in terms of cardiac safety.

Overview of our services:
- Human ion channel assays (manual or automated patch-clamp)
- MEA+Impedance
- Action potential recordings
- Human cardiomyocytes isolated from iPS cells
- ECG recordings and hemodynamic parameters (isolated Langendorff perfused heart)
- Isolated organ baths (Contractility, Spontaneous beating frequency, vasoreactivity)
- Compounds interaction
- Telemetry

Within Basel neighbourhood and at the very heart of Europe (the triple border of France, Germany and Switzerland), Firalis is a pioneering biotechnology company, active in discovery, development and qualification of biomarkers (BM).

1) BIOMARKER PRODUCTS
Firalis develops BM-based diagnostic, prognostic and theranostic tools:
● RUO Kits (Research-Use-Only), based on validated innovative biomarkers
● IVD Tools (In Vitro Diagnostic), based on a combination of clinically qualified biomarkers

2) BIOMARKER R&D
● Development of proprietary BMs
- Cardiovascular, Inflammatory, Autoimmune and Neurology
● Drug Safety & Drug Efficacy
● Patient Stratification
● Personalized Medicine

3) BIOMARKER-RELATED CRO SERVICES
BM Discovery for laboratories, biotechs and pharmaceutical industry:
- Proteomics: Soluble biomarker measurements with several immunoassays technologies (ELISA, multiplex and high sensitivity platforms such as Luminex® BioPlex 200™, Meso Scale Discovery®, Singulex Erenna®, Protein Simple Ella™, Olink and Siemens Dimension® EXL™ 200)
- Genomics/Transcriptomics: Targeted sequencing of miRNA and mRNA (HTG EdgeSeq), lncRNA screening via Firalis proprietary platform, Next-Generation Sequencing (NGS) services (RNA-Seq, whole genome and exome sequencing, etc.) and qPCR/microfluidic qPCR (Gene Expression, SNP, CNV, etc.)
- Flow Cytometry: Immunophenotyping of preclinical and clinical samples, monitoring of pharmacodynamics on target cells in response to treatment and biomarker discovery
- Assay development and validation on various platforms, development of critical reagents (antibodies and proteins)
- Biobanking and sample repository services supported by LIMS
- Data analysis using multi-parametric statistics and development of predictive models
- Support of regulatory activities related to biomarker qualification with Health Authorities (FDA/EMA)
- Quality environment (ISO 9001, ISO 13485 (GMP), ISO 17025 (GLP/GCLP))

For more information please visit our website.

PamGene is a functional proteomics Company with a unique 3D array platform to measure the ACTIVITY of Tyrosine and Serine/Threonine kinase.

We offer Products (described in our Showcase pages, PamStation-12 ®, Pamchip arrays ® and Reagent kits) and Services (lead optimization, translational/ preclinical research and biomarker discovery). We have developed powerful software tools (BioNavigator) for complex data analysis with which you can interpret results in a biological context. We support clinical trials in the oncology area.

Pamgene is advancing research in Oncology as well as other areas (Neurobiology, Immunology, Metabolic disorders, cardiovascular respiratory diseases). Our technology has a wide range of Applications from fundamental and discovery research to clinical development of therapeutic and diagnostic biomarkers.

Our patented technology stands out in allowing scientists in industry and academia to measure enzyme activity within a cellular context and fully decorated proteins. The assays have high sensitivity, broad kinome coverage and works for many sample sources.

PamGene has a strong science foundation and the number of publications applying our technology continues to rise. PamGene's Customer Service team supports your research with dedication. The PamAcademy offers advanced training, from workflows to data analysis, interpretation and storage. PamGene's PamCloud space allows User-interaction and furthers knowledge exploration.

Please visit our web site for further information (https://www.pamgene.com/) and get in touch with us! (https://www.pamgene.com/en/landing.htm)

Accell Clinical Research is an international full-service Contract Research Organization (CRO) managing Phase I-III clinical trials for 10+ years across Eastern Europe. With local presence, including highly qualified medical staff and legal entities in the region, we successfully recruit patients both in EU and outside EU in post-Soviet countries (CIS). All together we provide guaranteed fast patient recruitment in 20+ countries across the region.

⬇︎ ACCELL'S SERVICES for Phase I-III clinical trials:

• Strategic guidance and trial set-up:
• Feasibility research and site selection
• Study documentation development
• Regulatory support
• Clinical supply import and management
• Selection and management of clinical study vendors
• Project management
• Clinical & medical monitoring
• Data management and biostatistics
• Quality assurance
• Safety management
• TMF/eTMF services
• Functional outsourcing of a clinical team

⬇︎ THERAPEUTIC AREAS
• Oncology
• Cardiovascular
• Immunology
• Gastroenterology
• Neurology
• Endocrinology

AKRN Scientific Consulting is a clinical research and regulatory consulting firm for medical devices and IVD.

AKRN is based in Spain and Sweden.

We provide clinical development services on a stand-alone basis, or as part of an integrated full-service solution together with our European CRO-partners.

Our clients include MedTech start-up companies as well as multi-national companies.

We are committed to partner with Medical Device companies developing innovative technologies improving health care for more people.

We are highly qualified, experienced, and accountable clinical research professionals that guarantee cost-effective and successful solutions crafted to each client’s needs. We combine therapeutic expertise and decades of industry know-how with excellent service and responsiveness to support our customers with solutions that can stand up to rigorous scientific and regulatory evaluations.

We follow the national and international current standards (ICH/GCP guidelines, European regulations, and national and regional legislation), and the client or AKRN internal SOPs.

Services:
-Clinical Trial Services
-Clinical Strategy and Planning
-Study Design
-Clinical Monitoring
-Post Market Clinical Follow Up PMCF

Regulatory Services:
-CE Mark Strategic Planning
-Technical File | Design Dossier
-EU MDD to MDR Transition
-EU IVDD to IVDR Transition
-Clinical Evaluation Report CER

Key Medical Areas:

In-Vitro Diagnostic IVD

Cardiovascular
-Heart Valve Disease
-Aortic Disease
-Atrial Fibrillation
-Coronary Artery Disease
-Hypertension
-Endovascular Aortic Repair EVAR
-Percutaneous Coronary Interventions PCI
-Transcatheter Aortic Valve Implantation TAVI

Neurovascular
-Neuromodulation
-Spinal Cord Injuries
-Neurovascular Mechanical Thrombectomy

General
-Critical Care and Sepsis Management
-Minimal Invasive Surgery

Software
-AI | Machine Learning
-MDSW | SaMD

Odontology
-Implant and Digital Dentistry

Endocrinology
-Endocrinology and Diabetes