ACI Clinical

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

Our vision is to conduct clinical trials better and more cost effectively than anyone else. We accomplish this by working with our clients to not only deliver the clinical trial effectively, on time and within budget, but also by leveraging our in-depth expertise to ensure the clinical trial is properly designed.

We believe there is increasing need for innovation, creativity and scientific expertise in clinical research, characteristics often synonymous with small Biopharma and hence, though we are proud to have a number of the world’s largest pharmaceutical companies as our clients, greater than 80% of our client portfolio is small Biopharma.

ACLIRES has performed trials for an international array of biotech companies as well as for some of the largest global pharmaceutical companies. With our broad access to patients and expertise, our aim is to rapidly initiate our client’s studies, even when a very special patient population is required.

Our services include:
- Early Phase Studies
- Late Phase Studies
- Recruitment
- Regulatory Affairs
- Monitoring
- Site Selection
- Scientific Services/Medical Writing
- Consulting
- Quality Management

Actimus Bio is an Clinical Research Organisation (CRO)

 Actimus Bio is pioneering a novel approach by addressing the needs of the pharmaceutical and biotech industry and partnering the development of medicines for the future.
 Actimus Bio facility is approved by Drugs Controller General of India (DCGI).
 Actimus Bio is a full service BA/BE CRO dedicated to meet the needs of pharmaceutical and biotechnology companies.
 Actimus Bio offers an extensive range of Clinical services including
o Study design,
o project management,
o Medical safety monitoring,
o Biostatistics,
o Quality assurance auditing,
o Regulatory submissions and scientific communications

Aepodia is specialized in the strategy and delivery of early drug and Medical Devices development and provides scientific consultancy as well as operational support across various indications including but not limited to CNS, Endocrinology, Metabolic Disease, Oncology...

Our very experienced clinical trial team can implement, manage and execute clinical trials, by offering “ad hoc” or “full services” support to complement the sponsor’s internal team (e.g., Regulatory Strategy, Study design, Project Coordination, Monitoring, Competent Authority Submission, Site Selection/Assessment/Management, Medical Writing …).

In addition to traditional services, Aepodia conducts preclinical and clinical Due Diligence to facilitate your out-licensing or in-licensing activities.

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