Cardialysis

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

ASCOPHARM Groupe NOVASCO Group represents one of the most proactive Contract Research Organization in the field of Clinical Research in Europe.

Founded in 1995 the original company, has now been raised to a full clinical and medical service group, together with original financial services dedicated to Clinical development.

The company has now specificities and expertise in a number of aspects of clinical research. ASCOPHARM Groupe NOVASCO have raised up expertise in certain therapeutic fields : Oncology, Transplant, Immune modulators, Rheumatology, Cardiovascular disease, Ophthalmology. The Group has also developed original services for site management and support (Site CRA services).

Together will all services offered, ASCOPHARM Groupe NOVASCO has strongly developed its expertise in Information Technologies and Computer Software. Original tools have been developed (eCRF, Project Management tools, etc…) and an IT company has been integrated to the group.

ASCOPHARM Groupe NOVASCO conducts activities in France and in most European countries.

Crown CRO is a privately owned Finnish CRO founded in 2005. Our headquarters are in Espoo, which is located in Finland’s capital city region. Crown CRO offices are located in Finland, Sweden, Denmark, Norway, Estonia, Latvia and Lithuania. We have ongoing trials managed by our employees in Netherlands, Belgium, UK, Iceland, Ukraine and Belarus. Rest of the Europe and USA we cover through our qualified CRO network.

Our services cover Phase I – IV clinical development from protocol design to final reporting or any parts of the trial in various business models. Data services, Regulatory consulting, Pharmacovigilance, QA, Study Rescue Services and Medical Translation services complete the service package.

Our key therapeutic areas include, but not limited to, CNS, Oncology, Endocrinology, Cardiovascular, Respiratory and Musculoskeletal. We also have strong recent experience in Medical Devices from various indications.

Our passion for research across all our in-house Full-Service functions provide effective and innovative solutions with seamless cooperation for Phase I-III trials in Europe offering special focus on Nordic-Baltic area, together with our own Global Data Services ensuring consistency regardless of where your trials are located, offer you unrivalled customer attention, flexibility and high local level expertise which are key assets you can count on.

See www.crowncro.com for more information.

EPHORAN Multi-Imaging Solutions is a Contract Research Organization providing imaging expertise and knowledge to study, develop and promote the application of imaging technologies in preclinical drug research and development.

EPHORAN provides the opportunity to apply a translational pharmacological approach in drug R&D, evaluating in animal models a molecular-based proof of biological activity and mechanism of action, and translating it into the clinical setting. All the Techniques extensively employed in the clinical setting(e.g. PET, CT, SPECT, MRI, US and in Optical Imaging, both visible light and Near Infra Red) are available.

EPHORAN fosters the development of diagnostic tools, reagents and methodologies for experimental imaging and makes the drug development faster and more cost effective. Pharmaceutical companies will take advantage from its preclinical imaging technologies to carry on more effectively their R&D projects in different therapeutic such as oncology, cardiovascular and CNS. The application of Imaging techniques allows a significant reduction of the time-to-market of novel compounds. Other users that will benefit from access to Ephoran’s services are Researchers from academic and research institution.