DURECT Corporation

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

Opened in 1915, Burke Rehabilitation Hospital has been a leader in medical rehabilitation for over 100 years.
Located in White Plains, NY, the 150-bed acute rehabilitation hospital treats patients who have experienced a stroke, spinal cord injury, brain injury, amputation, orthopedic surgery, cardiac and pulmonary disease, neurological disorders as well as general debility. Burke’s doctors, nurses and therapists provide state-of-the-art treatment, and our personalized care is the result of expert, interdisciplinary teams led by highly respected physicians. Our inpatient programs provide a minimum of 15 hours of physical, occupational and speech therapy per week. Burke is a member of the Montefiore Health System.
Burke also operates several outpatient rehabilitation clinics throughout Westchester County and the Bronx. These conveniently located clinics offer physical, occupational, speech and other specialty therapies; available services vary by location. All of Burke’s outpatient clinics provide the same excellent care Burke is known for close to home.
In 2017, Burke launched an outpatient physician practice on its main campus. Patients who have completed inpatient rehabilitation or members of the community seeking outpatient medical services can be evaluated by board-certified Burke/Montefiore physicians specializing in Physical Medicine & Rehabilitation. Treatment is available for patients who experience complications related to injury, illness or chronic conditions.
Burke is dedicated to training the next generation of rehabilitation professionals. The hospital is home to a nationally-recognized ACGME-accredited Physical Medical & Rehabilitation residency program. Burke also conducts cutting-edge clinical research. Patients admitted to Burke may have the opportunity to participate in medical research for ongoing studies.
The hospital’s team of experts coupled with a personalized care model have been getting patients back to the lives they love for over a century.

Children’s Medical Research Institute (CMRI) pioneered microsurgery, immunisations against lethal childhood illnesses, and care for premature babies, all of which has improved the lives of countless Australian children.

The work at CMRI is made possible by a network of devoted community supporters and Jeans for Genes®, the iconic fundraising campaign established in 1994 to fund revolutionary research that helps diagnose, understand, and find cures or treatments for conditions affecting kids.

Today, CMRI is an independent institute and the site of world-leading research in the areas of cancer, neurobiology, embryology, proteogenomics and gene therapy. CMRI is affiliated with the University of Sydney and is a founding partner of Paediatrio and the Westmead Research Hub.

CMRI collaborates with scientists all over the world to push research forward. It also provides important resources for scientists in Australia. It operates CellBank Australia™, the only national repository of cell cultures in Australia, necessary for many fields of medical science; as well as advanced gene therapy and gene engineering facilities--creating treatments of the future. In addition, CMRI houses the ACRF Cancer Centre, which includes the ACRF Centre for Kinomics, ACRF Telomere Analysis Centre and ACRF ProCan®, whose combined efforts are to understand, improve diagnosis, survivability and discover new treatments for all types of cancer.

Immunetrics takes a Quantitative Systems Pharmacology (QSP) approach to creating mechanistic mathematical models of biological systems, accelerating development of drugs, clinical diagnostics, and medical/commercial devices. We predict FDA-approved endpoints through in silico clinical trial simulations of acute or chronic inflammatory diseases. We deliver proprietary mathematical models encompassing biological pathways and interactions that span levels of detail from intracellular signaling pathways, cell-cell interactions, and organ systems. We also utilize complex analyses to help better understand your data and create novel hypotheses. Our robust bio-simulation platform represents 10+ years of work by our team of experts. Our capabilities allow our clients to bring their health care solutions to market more quickly, at a lower cost, and with decreased risk.

Immunetrics was founded in 2001 and collaborates regularly with the most significant names in drug development, medical devices, and academia.

Our team includes a cross disciplinary group of experts in physiology, molecular biology, immunology, computational biology, machine learning, and software engineering in a highly collaborative environment. We provide the expertise and experience to build functional models to inform our clients in their decision making process.

Immunetrics'​ offices and computing center are conveniently located in South Side of Pittsburgh, PA. Our city is the home of the University of Pittsburgh Medical Center, with its world-class Critical Care Medicine, Surgery and Immunology departments; Carnegie Mellon University, with its world-renowned Engineering and Mathematics groups; and the Pittsburgh Supercomputing Center.

Intelon Optics Inc. is a medical device company focusing on the development and commercialization of the Brillouin Optical Scanner System (BOSS™), a technology that enables next-generation point-by-point biomechanical imaging of eye structures, extending from the cornea to the posterior part of the globe.

BOSS™ brings a wide range of novel diagnostic and surgical solutions to empower eye care professionals with high-level decision making confidence and control based on biomechanical tissue properties of the eye.

The biomechanics - or biomechanical properties - are primary and critical factors directly impacting the functionality of the eye as a refractive system. They affect functional responses of the cornea and the crystalline lens to light and greatly impact vision.

The company’s commercial focus begins with refractive surgery, and extends to other diagnostic and surgical areas in eye care. The company’s products will bring novel and unique solutions to allow deterministic surgical outcomes, control of treatment results, and a high level of decision-making confidence to clinicians and surgeons based on biomechanical tissue properties relevant to refractive error correction.

To date, BOSS™ is the only technology allowing in-vivo, localized measurement of Young’s modulus, a direct measure of the stress-strain relationship of ocular tissues influencing the refractive performance of the eye from the cornea where the light enters the eye to the retina - the sensory system.

Those solutions will eventually be offered to a broad range of customers, ranging from research institutions to health care providers in a multitude of international markets, and as OEM solutions to multi-national corporations.

Disclaimer: BOSS™ and any products described on this wpage are not approved by the Food and Drug Administration (FDA) for use in the United States, nor are they currently pending FDA regulatory approval. The BOSS™ has received CE Mark Certification for us