DHD-Consulting GmbH

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

AmeRuss Clinical Trials, LLC (headquartered in the US, Arizona) is a next generation CRO that provides comprehensive integrated clinical development solutions to Pharma, Biotech and Medical Device companies.

AmeRuss successfully operates in Russia, CIS, Baltic States, Europe, Caucasia and MENA countries.

We have the capability to conduct full service clinical trials from phase I to phase IV (including observational NIS, registries, Investigator Initiated Studies) and bring the highest quality standards at every step of the trial: protocol design, monitoring, project management, data management, statistical analysis, QA, Pharmacovigilance, Clinical Logistics, GCP trainings, publications, etc.

As a sponsor, you can expect a deep personal attention, flexible approach and a high quality work done within tough timelines.

AmeRuss is a ISO 9001-2008 certified company, and acts in accordance with the international standards and guidance such as ICH GCP, ISO 14155:2011 and other local regulatory requirements.

Please, visit us at:
www.ameruss.com

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.

Paracelsis is a preclinical/nonclinical contract research organisation (CRO); the companies mission is to provide its customers (pharma and biotech companies, academic institutions etc.) with a comprehensive 'one-stop' solution with respect to their preclinical/nonclinical development needs.

We have a proven track record spanning the lifecycle of preclinical development ranging from the conduct of proof-of-concept pharmacokinetic and tolerability studies through to GLP toxicology studies and drafting of scientific documents to support pharma/biotech products through various stages of clinical development and ultimately to market approvals in Europe, USA and Australia. Of particular note is our extensive experience of evaluating nasal drug products and intranasal drug delivery systems.

Paracelsis offers an eclectic mix of laboratory-based and consultancy services in the preclinical setting which can be tailored and aligned according to customer needs, stage of product development, etc.

Laboratory-based (in-house) studies
•In vivo pharmacokinetic and tolerability studies
•In vivo non-invasive imaging studies (e.g. gamma scintigraphy, magnetic resonance imaging)
•Pharmacokinetic data analysis using Phoenix WinNonlin (clinical and preclinical datasets)

Laboratory-based (outsourced) studies
•GLP toxicology studies (including CRO selection, protocol generation, study monitoring and reporting)
•In silico (computer-based) predictive toxicology (e.g. using Lhasa’s Derek Nexus and Leadscope software)

Consultancy
•Safety (toxicological) assessments on drugs, metabolites, excipients, impurities, extractables and leachables etc.
•Expert interpretations
•Scientific reports and documents to support regulatory and ethical submissions (CTA/IND, MAA/NDA etc.)
•Representation at meetings with regulatory agencies
•Assessment of preclinical development needs and generation of preclinical development plans
•Project management

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