Prosoft Clinical
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Prosoft Clinical Services and Capabilities provides clinical trial services including CMC formulation development, biostatistics, data management, clinical operations, medical writing, and regulatory strategy and operations. They have experience across multiple therapeutic areas like allergy/respiratory, CNS, dermatology, heart failure, HIV, hypertension, oncology, pain, and women's health. Their team has extensive experience developing products through all phases of clinical trials and regulatory approval.
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510K Table of Contents - Medical Device Description
As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.
Brochure e-GCR Biopharma
Most of clinical trials are delayed because recruitment rates do not meet expectations, due to the growing complexity of protocols. North Africa possesses all the features to be an interesting area for numerous clinical trials…..
La plupart des essais cliniques sont annulés, à cause d’un taux de recrutement bas, qui ne satisfait pas les attentes. Cette baisse est due à une croissance de la complexité des projets de recherche. L’Afrique du Nord possède des atouts intéressants favorables pour le déroulement des essais cliniques…..
http://www.e-gcr.com/
FDA Guidance and Clinical Trials
The Food and Drug Administration (FDA) released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. Why? To standardize. To automate. To move closer to zero-delay clinical trials. Read AG Mednet's perspective on this FDA guidance.
Software As Device - Frank Maxwell
1. The document analyzes how software would be classified under the EU Medical Device Directive and the US Medical Device Data Systems regulation by applying them to a private hospital's software catalog.
2. There are significant differences in how software would be classified under each regulation. The EU regulation considers more software to be medical devices than the US regulation.
3. If bespoke healthcare IT is developed, the hospital could be considered a medical device manufacturer under the EU regulation but not necessarily under the US regulation.
4. Further research is needed on how complementary standards and guidelines could apply, how software evaluation and vendor selection may differ between public and private institutions, and how regulations apply to software in general practitioner offices.
New FDA Refuse to Accept Policy for 510(k)s and Acceptance Review Process for...
This presentation covers what the Acceptance Review is along with some of the frequently missed criteria for 510(k)s and PMAs.
Real-World Evidence: The Future of Data Generation and Usage
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Abbreviated 510(k)
Premier Device Consultants was contracted to develop a regulatory strategy for the Laser Therapeutics Company's new medical device called NEULASER, which uses lasers for eye surgery. Premier determined NEULASER is a Class II device that can be cleared through an abbreviated 510(k) by demonstrating substantial equivalence to similar predicate devices. Premier recommended establishing quality management systems, developing documentation for design controls and postmarket surveillance, and preparing all required documents and user fees for the 510(k) submission to obtain FDA clearance to market NEULASER in the United States by the second quarter of 2015.
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The CLARITY Aneurysm Clip is intended for permanent occlusion of cerebral aneurysms. It is made of PEEK polymer, while the predicate Sugita Titanium Aneurysm Clip is made of Elgiloy alloy. Testing showed the CLARITY Clip performs comparable to the predicate in biocompatibility, corrosion resistance, and MRI safety. Though different materials, the CLARITY Clip's intended use, jaw-based occlusion mechanism, and substantial equivalence to the RoG Suture Anchor reference device support that it is as safe and effective as existing aneurysm clips.Recommended
510K Table of Contents - Medical Device Description
As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.
Brochure e-GCR Biopharma
Most of clinical trials are delayed because recruitment rates do not meet expectations, due to the growing complexity of protocols. North Africa possesses all the features to be an interesting area for numerous clinical trials…..
La plupart des essais cliniques sont annulés, à cause d’un taux de recrutement bas, qui ne satisfait pas les attentes. Cette baisse est due à une croissance de la complexité des projets de recherche. L’Afrique du Nord possède des atouts intéressants favorables pour le déroulement des essais cliniques…..
http://www.e-gcr.com/
FDA Guidance and Clinical Trials
The Food and Drug Administration (FDA) released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. Why? To standardize. To automate. To move closer to zero-delay clinical trials. Read AG Mednet's perspective on this FDA guidance.
Software As Device - Frank Maxwell
1. The document analyzes how software would be classified under the EU Medical Device Directive and the US Medical Device Data Systems regulation by applying them to a private hospital's software catalog.
2. There are significant differences in how software would be classified under each regulation. The EU regulation considers more software to be medical devices than the US regulation.
3. If bespoke healthcare IT is developed, the hospital could be considered a medical device manufacturer under the EU regulation but not necessarily under the US regulation.
4. Further research is needed on how complementary standards and guidelines could apply, how software evaluation and vendor selection may differ between public and private institutions, and how regulations apply to software in general practitioner offices.
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This presentation covers what the Acceptance Review is along with some of the frequently missed criteria for 510(k)s and PMAs.
Real-World Evidence: The Future of Data Generation and Usage
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Abbreviated 510(k)
Premier Device Consultants was contracted to develop a regulatory strategy for the Laser Therapeutics Company's new medical device called NEULASER, which uses lasers for eye surgery. Premier determined NEULASER is a Class II device that can be cleared through an abbreviated 510(k) by demonstrating substantial equivalence to similar predicate devices. Premier recommended establishing quality management systems, developing documentation for design controls and postmarket surveillance, and preparing all required documents and user fees for the 510(k) submission to obtain FDA clearance to market NEULASER in the United States by the second quarter of 2015.
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mock 510(k) for UCSC Extension Regulatory Submissions Devices and Diagnostics...Joanne Pelaschier, RAC, CQA, CQE
The CLARITY Aneurysm Clip is intended for permanent occlusion of cerebral aneurysms. It is made of PEEK polymer, while the predicate Sugita Titanium Aneurysm Clip is made of Elgiloy alloy. Testing showed the CLARITY Clip performs comparable to the predicate in biocompatibility, corrosion resistance, and MRI safety. Though different materials, the CLARITY Clip's intended use, jaw-based occlusion mechanism, and substantial equivalence to the RoG Suture Anchor reference device support that it is as safe and effective as existing aneurysm clips.Ophthalmic Innovation 2016 - "A View From The AAO"
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Presenter:
David Parke, II, MD, CEO
Powered by:
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TestSafe is a clinical data repository that stores laboratory test results for over 600,000 patients across multiple hospitals and primary care providers in the Auckland region of New Zealand. It aims to improve healthcare by providing authorized medical professionals secure access to complete patient test histories, which can reduce unnecessary repeat tests and support faster diagnosis. The repository maintains strong privacy controls like optional patient "opt outs", restrictions placed by providers on a per-patient or per-episode basis, and comprehensive logging of all access for auditing purposes. After its first year of operation, around 15% of over 5.9 million stored test groups had been viewed, and privacy controls were utilized relatively infrequently, suggesting it is achieving its goals while protecting confidentiality.
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While anemia is a common condition, it can be challenging to address because of its multifactorial and complex nature. As a result, diagnosis and management for some patients may be suboptimal. According to the Royal Society of Medicine, anemia is in many cases poorly assessed or not investigated and there are currently no defined national guidelines on management pathways.
A shareable clinical pathway is a visual model that is both human readable and machine automatable. Such a standardized process can improve the efficiency and quality of anemia treatments through improved workflows and better clinical decisions. Automation allows routine tasks to be handled effectively, leaving more time to address complex cases, while the visual representation enables the transparency needed for all stakeholders to understand what has happened and why.
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This document summarizes a presentation about US FDA regulation updates regarding electronic submissions. It discusses the FDA Electronic Submission Gateway (ESG), which provides a single entry point for securely submitting electronic documents. The ESG aims to automate processes, support electronic submissions in a standard format, and route submissions to the appropriate FDA center. The presentation also covers FDA initiatives for electronic submissions for drugs, biologics, devices, and other product types. It provides information on how to set up for electronic submissions using the ESG.
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Video Presentation:
https://www.youtube.com/watch?v=CWwqmEDJOhM&index=20&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
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Actimus Biosciences Pvt Ltd is a clinical research organization founded in 2005 in Visakhapatnam, India. It is led by Chairman and Managing Director Ramnath Reddy, who has experience in the healthcare and pharmaceutical industries. The company has facilities for clinical trials including two clinics with 72 beds and laboratories equipped for bioanalytical work. It provides clinical trial services and has experience conducting over 350 studies.
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I was coordinator of the software development of a project in the European Commission’ Telematic Applications Programme, DG XIII entitled “The Black Sea Tele Diab System (BSTD)”. The project was the result of a collaboration between members of the BSTD consortium, made up of the following partners: University of Sheffield (project coordinator) and University of Hull, UK; Research Institute and Diabetes Center, Greece; Institute of Diabetes, Nutrition and Metabolic Diseases, “N. Paulescu” and the Romanian Society Clinical Engineering and Medical Computing, Bucharest, Romania; Gorky State Medical University, Ukraine; Centre for Pathology, Chisinau, Moldova.
This system was carefully constructed and developed to meet the requirements to encourage clinicians to abandon paper records in favor of a fully-computerized healthcare record system and to promote the electronic exchange of healthcare information between clinicians and scientists in countries of the Black Sea area. The system was developed using a modular design and object oriented method approach. It was developped based on the Good European Health Record (GEHR) Architecture that faithfully preserving the data as originally intended, as well as permitting analysis of the data, which can come from many sources using an XML exchange method.
The GEHR structure is very comprehensive, data items being stored in a number of related tables that are held in a MS Access database. The software for the system has been developed in Microsoft Visual C++ and when combined with the database, it provides an application that is fast and well integrated with the Windows environment. Development of the system has followed a stepwise approach with validation of the architecture and the incorporation of feedback from users at each key stage.
There are five major work areas: patient records, reports, graphs, Diabetes Aggregated Data (DAD) and administration. Each of these contains a number of individual application/functions which are serviced by the relational tables that store the patient details, clinical measurements, doctors and user information. The Patient Records Function offers options for the management of the EHCRs (creation/correction/visualisation), such as: registration of a new patient and entry of the first record or sheet; the recording of a new sheet; the correction/visualisation of the sheet; the recording of data about the patient’s death, etc. The System Administration Function allows: Definition of the health care facility; definition of persons as users or system managers; management of passwords and access rights for the users; definition of measurement units; limited customisation of the user interface.
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Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
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Guide Preview: The importance of using an accredited enterprise image-viewing...
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The Healthcare industry is more dynamic than ever before. Innovative technologies have significantly enhanced the way medical practitioners diagnose patients, review images, seek second opinions, communicate results and generally approach the care they give. According to the Government Accountability Office, 75% of all imaging procedures are performed outside of the hospital setting. Because images are now being accessed remotely, it has become crucial to understand if the technology has been accredited. If it has not, diagnosis or treatment decisions using that technology should never be made.
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The MedWatch program allows health professionals and the public to voluntarily report serious reactions to medical products like drugs and devices. These reports are entered into the FDA Adverse Event Reporting System (FAERS) database. The goals of MedWatch are to increase awareness of medical product risks, clarify what should be reported, and provide safety information on FDA-regulated products to healthcare providers and patients. While FAERS supports post-marketing safety surveillance, it has limitations as not all adverse events are reported.
Carpathian Research Group LLC
Headquartered in Ukraine Carpathian Research Group LLC is a privately-owned clinical research organization (CRO) supporting broad range of R&D activities for biopharmaceutical and medical device industry across Ukraine and neighbouring countries (including, but not limited to Georgia, Moldova, Turkey, Romania, Bulgaria, Kazakhstan, Uzbekistan and Belarus).
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Cloud agnostic pre post operative remote automated monitoring of patients
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Real-world Evidence A Saudi Regulatory Perspective
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CXAIR structuring data for inclusion in COSD for the NHS
Alongside many other changes occurring in the NHS lately, the way in which Cancer Services are reporting on their data has been reformed. The Government believe these changes are necessary requirements to improve patient outcomes for those diagnosed with Cancer, and will aid reaching the latest government target of saving over 5000 additional lives each year.
See how CXAIR can help solve the challenges of these requirements.
Lab Software
HospitalSoftwareShop.com is probably India's first online store for software for consulting physicians, cardiologists, gastrologists, nephrologists, ophthalmologists, andrology experts, infertility specialists, physicians, Doctors, Specialists & Clinics including Prescription Writing, Electronic Health Records, Electronic Medical Records and Practice Management. All these softwares have been developed after years of research and valuable inputs from specialists located throughout India. These software are easy to use, require very less typing, works quickly and saves precious practice time.
This software is specially designed for Infertility Management experts, IVF Experts, IUI Experts. It is a very robust software, easy to use and requires minimum typing. It covers these aspects:
Menstrual / Personal / Obstetric History
Primary / Secondary Infertility
TB, DM & HT History
DNC Parameters
Surgical History: Laparoscopy / Hysteroscopy / HSG
Surgical Treatment
Infertility Treatment: IUI / IVF / ICSI
Ovulation Study
Visit: www.hospitalsoftwareshop.com for more details.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
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Lab Equipments By Thermo Fisher Scientific India Pvt. Ltd, Mumbai
Thermo Fisher Scientific India Pvt. Ltd. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and approximately 55,000 employees globally. Our mission through our premier brands Thermo Scientific, Applied Bio Systems, Invitrogen, Fisher Scientific and Unity Lab Services, we offer an unmatched combination of innovative is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. We offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
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TestSafe is a clinical data repository that stores laboratory test results for over 600,000 patients across multiple hospitals and primary care providers in the Auckland region of New Zealand. It aims to improve healthcare by providing authorized medical professionals secure access to complete patient test histories, which can reduce unnecessary repeat tests and support faster diagnosis. The repository maintains strong privacy controls like optional patient "opt outs", restrictions placed by providers on a per-patient or per-episode basis, and comprehensive logging of all access for auditing purposes. After its first year of operation, around 15% of over 5.9 million stored test groups had been viewed, and privacy controls were utilized relatively infrequently, suggesting it is achieving its goals while protecting confidentiality.
A Shareable Clinical Pathway for Anemia Management John Svirbely and Denis ...
While anemia is a common condition, it can be challenging to address because of its multifactorial and complex nature. As a result, diagnosis and management for some patients may be suboptimal. According to the Royal Society of Medicine, anemia is in many cases poorly assessed or not investigated and there are currently no defined national guidelines on management pathways.
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Electronic Submissions
This document summarizes a presentation about US FDA regulation updates regarding electronic submissions. It discusses the FDA Electronic Submission Gateway (ESG), which provides a single entry point for securely submitting electronic documents. The ESG aims to automate processes, support electronic submissions in a standard format, and route submissions to the appropriate FDA center. The presentation also covers FDA initiatives for electronic submissions for drugs, biologics, devices, and other product types. It provides information on how to set up for electronic submissions using the ESG.
HospitalSoftwareShop - Laboratory Information System LIS
HospitalSoftwareShop provides exhaustive LIS Software - Laboratory Information System -for Pathology Labs. Being web-based makes lab software globally accessible. Software for labs offers widest range of pathology tests, direct integration with lab equipment without manual intervention reduces errors and time
OPHTHALMOLOGY INNOVATION SHOWCASE - Cassini
Presentation from OIS@ASCRS 2016
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Video Presentation:
https://www.youtube.com/watch?v=CWwqmEDJOhM&index=20&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
Actimus Biosciences
Actimus Biosciences Pvt Ltd is a clinical research organization founded in 2005 in Visakhapatnam, India. It is led by Chairman and Managing Director Ramnath Reddy, who has experience in the healthcare and pharmaceutical industries. The company has facilities for clinical trials including two clinics with 72 beds and laboratories equipped for bioanalytical work. It provides clinical trial services and has experience conducting over 350 studies.
BlackSea TeleDiab
I was coordinator of the software development of a project in the European Commission’ Telematic Applications Programme, DG XIII entitled “The Black Sea Tele Diab System (BSTD)”. The project was the result of a collaboration between members of the BSTD consortium, made up of the following partners: University of Sheffield (project coordinator) and University of Hull, UK; Research Institute and Diabetes Center, Greece; Institute of Diabetes, Nutrition and Metabolic Diseases, “N. Paulescu” and the Romanian Society Clinical Engineering and Medical Computing, Bucharest, Romania; Gorky State Medical University, Ukraine; Centre for Pathology, Chisinau, Moldova.
This system was carefully constructed and developed to meet the requirements to encourage clinicians to abandon paper records in favor of a fully-computerized healthcare record system and to promote the electronic exchange of healthcare information between clinicians and scientists in countries of the Black Sea area. The system was developed using a modular design and object oriented method approach. It was developped based on the Good European Health Record (GEHR) Architecture that faithfully preserving the data as originally intended, as well as permitting analysis of the data, which can come from many sources using an XML exchange method.
The GEHR structure is very comprehensive, data items being stored in a number of related tables that are held in a MS Access database. The software for the system has been developed in Microsoft Visual C++ and when combined with the database, it provides an application that is fast and well integrated with the Windows environment. Development of the system has followed a stepwise approach with validation of the architecture and the incorporation of feedback from users at each key stage.
There are five major work areas: patient records, reports, graphs, Diabetes Aggregated Data (DAD) and administration. Each of these contains a number of individual application/functions which are serviced by the relational tables that store the patient details, clinical measurements, doctors and user information. The Patient Records Function offers options for the management of the EHCRs (creation/correction/visualisation), such as: registration of a new patient and entry of the first record or sheet; the recording of a new sheet; the correction/visualisation of the sheet; the recording of data about the patient’s death, etc. The System Administration Function allows: Definition of the health care facility; definition of persons as users or system managers; management of passwords and access rights for the users; definition of measurement units; limited customisation of the user interface.
Cell & Gene Therapy Post-Approval Solutions
Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy Post-Approval Solutions
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Guide Preview: The importance of using an accredited enterprise image-viewing...
Guide Preview: The importance of using an accredited enterprise image-viewing...Calgary Scientific Inc.
The Healthcare industry is more dynamic than ever before. Innovative technologies have significantly enhanced the way medical practitioners diagnose patients, review images, seek second opinions, communicate results and generally approach the care they give. According to the Government Accountability Office, 75% of all imaging procedures are performed outside of the hospital setting. Because images are now being accessed remotely, it has become crucial to understand if the technology has been accredited. If it has not, diagnosis or treatment decisions using that technology should never be made.
This guide describes how to decipher between an accredited and non-accredited enterprise image-viewing solutions and the risks of not understanding the differences. http://offers.calgaryscientific.com/resolutionmd4-guidesMedwatch and FAERS database
The MedWatch program allows health professionals and the public to voluntarily report serious reactions to medical products like drugs and devices. These reports are entered into the FDA Adverse Event Reporting System (FAERS) database. The goals of MedWatch are to increase awareness of medical product risks, clarify what should be reported, and provide safety information on FDA-regulated products to healthcare providers and patients. While FAERS supports post-marketing safety surveillance, it has limitations as not all adverse events are reported.
Carpathian Research Group LLC
Headquartered in Ukraine Carpathian Research Group LLC is a privately-owned clinical research organization (CRO) supporting broad range of R&D activities for biopharmaceutical and medical device industry across Ukraine and neighbouring countries (including, but not limited to Georgia, Moldova, Turkey, Romania, Bulgaria, Kazakhstan, Uzbekistan and Belarus).
Rfid based automatic scoring system for physical fitness testing
I3E Technologies,
#23/A, 2nd Floor SKS Complex, Opp. Bus Stand, Karur-639 001.
IEEE PROJECTS AVAILABLE,
NON-IEEE PROJECTS AVAILABLE,
APPLICATION BASED PROJECTS AVAILABLE,
MINI-PROJECTS AVAILABLE.
SPOTLIGHT ON MIGS - InnFocus
Presentation from OIS@ASCRS 2016
Russ Trenary, President & CEO
Video Presentation:
https://www.youtube.com/watch?v=xMfqxDsyA8M&index=25&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw
Cloud agnostic pre post operative remote automated monitoring of patients
The cloud agnostic solution is designed such a way that it is compatible with AWS and Azure cloud services.
Real-world Evidence A Saudi Regulatory Perspective
By Mr. Turki A. Al-Thunian, Bpharm, MClinPharm, MSc.Epi, PhD, Acting Director of the Research Informatics Department, Saudi Food and Drug Authority (SFDA), delivered at the Global Forum 2020 Drug Safety and Supply Chains session.
CXAIR structuring data for inclusion in COSD for the NHS
Alongside many other changes occurring in the NHS lately, the way in which Cancer Services are reporting on their data has been reformed. The Government believe these changes are necessary requirements to improve patient outcomes for those diagnosed with Cancer, and will aid reaching the latest government target of saving over 5000 additional lives each year.
See how CXAIR can help solve the challenges of these requirements.
Lab Software
HospitalSoftwareShop.com is probably India's first online store for software for consulting physicians, cardiologists, gastrologists, nephrologists, ophthalmologists, andrology experts, infertility specialists, physicians, Doctors, Specialists & Clinics including Prescription Writing, Electronic Health Records, Electronic Medical Records and Practice Management. All these softwares have been developed after years of research and valuable inputs from specialists located throughout India. These software are easy to use, require very less typing, works quickly and saves precious practice time.
This software is specially designed for Infertility Management experts, IVF Experts, IUI Experts. It is a very robust software, easy to use and requires minimum typing. It covers these aspects:
Menstrual / Personal / Obstetric History
Primary / Secondary Infertility
TB, DM & HT History
DNC Parameters
Surgical History: Laparoscopy / Hysteroscopy / HSG
Surgical Treatment
Infertility Treatment: IUI / IVF / ICSI
Ovulation Study
Visit: www.hospitalsoftwareshop.com for more details.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
What's hot (20)
Ophthalmic Innovation 2016 - "A View From The AAO"
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A Shareable Clinical Pathway for Anemia Management John Svirbely and Denis ...
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HospitalSoftwareShop - Laboratory Information System LIS
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Guide Preview: The importance of using an accredited enterprise image-viewing...
Guide Preview: The importance of using an accredited enterprise image-viewing...
Rfid based automatic scoring system for physical fitness testing
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Real-world Evidence A Saudi Regulatory Perspective
CXAIR structuring data for inclusion in COSD for the NHS
CXAIR structuring data for inclusion in COSD for the NHS
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...
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Presentation China And Usa July 2011
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
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SNUBH has undergone a digital transformation journey over the past decade, evolving from a partially digital hospital in 2010 to a fully digital hospital today. Key milestones in SNUBH's digital transformation included implementing an integrated hospital information system (HIS) called BESTCare, expanding telehealth services, and establishing a health information exchange. More recently, SNUBH has focused on developing next generation technologies like mobile EMR, dashboards, smart beds, and a patient portal. SNUBH has also successfully expanded its digital hospital expertise internationally, implementing its HIS in hospitals in Saudi Arabia and the United Arab Emirates. Moving forward, SNUBH aims to further advance personalized medicine through closed loop systems, continuous patient monitoring, and
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QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
Wincere Inc.
This document provides an overview of the services offered by a global clinical research organization (CRO).
The CRO has capabilities across the clinical trial lifecycle including study database development, clinical data management, statistical programming, clinical programming and reporting, pharmacovigilance, quality assurance and compliance, and regulatory affairs.
The CRO aims to reduce costs for clients by offering remote resources and resources across various locations globally. Analytics solutions and risk-based monitoring tools are also available to enhance efficiency and data quality. Medical writing, scientific communications, and drug safety services round out the CRO's service offerings.
Progamma Us
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
High Quality Integrated Drug R&D Services
End-to-end services and solutions covering the entire spectrum of preclinical biopharmaceutical R&D. Supporting everything from target discovery, candidate development, preclinical screening and drug safety evaluation through IND submission. https://www.medicilon.com/about-medicilon/
Network, Technology, and Data: Missing Pieces of the Puzzle for Clinical Tria...
There is a massive shortfall in the enrollment and accrual of patients for clinical trials. Identifying the “right patients for the right trials at the right time” is a growing concern for providers, pharmaceutical companies, and clinical research organizations. In this webinar, we will discuss the evolution of clinical trials, including how to break barriers to enable successful clinical research as a care option, how clinical research impacts patient satisfaction and revenue, and more.
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Bridging Health Care and Clinical Trial Data through Technology
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HealthBIO 2021_PerkinElmer, leading with innovation - from COVID success into...
This document provides an overview of PerkinElmer, a company focused on diagnostics, life sciences, food, and applied markets. It discusses their mission of innovating for a healthier world, with over 80 years of innovations including a COVID-19 PCR kit launched in 2020. The company's diagnostics segment focuses on reproductive health, immunoassays, and applied genomics. PerkinElmer has global capabilities across molecular diagnostics, imaging, automation, and more. It is pursuing growth in areas like single-cell analysis, therapeutics, digital solutions, and decentralized testing. The company's strategy focuses on detection, decentralization, and digitization to drive profitable growth.
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This document is the contract services directory from Contract Pharma magazine. It lists over 200 categories of contract services for the pharmaceutical industry, ranging from analytical testing and clinical research to manufacturing, packaging, and regulatory support. The directory acts as a buyers' guide for those seeking external partners and providers across the drug development and production process.
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This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses who they are, what services they provide, their global regulatory experience, and two case studies. Key details include that Pharmalink has 155 staff, works with 18 of the top 20 healthcare companies, provides regulatory solutions across the product lifecycle, has offices and affiliates worldwide, and has experience helping clients with projects of all sizes involving domestic, international, and multinational regulatory requirements. Their case studies describe large-scale compliance and biosimilar product review projects for pharmaceutical clients.
AXIS Clinicals Corporate Presentation
AXIS Clinicals, a privately-owned well established full-service CRO (Contract Research Organization) headquartered in Hyderabad, India
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If PMA, Clinical Data is NeededOmni Comm Systems
OmniComm Systems provides web-based EDC and clinical trial management software and services. It has offices in the US and Europe. Its flagship product, TrialMaster v4.0, is a full-featured EDC platform that allows users to design and manage clinical trials, collect and validate data, generate reports, and monitor trials. OmniComm reported higher net income in 2008 than 2007 and provides training and customer support services to support its EDC software.
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This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses Pharmalink's history, capabilities, experience, and case studies. Pharmalink was founded in 1998 and works with 18 of the top 20 healthcare companies. They have offices globally and can provide regulatory assistance across the entire product lifecycle from non-clinical development to post-approval tasks. Case studies demonstrate experience with large, global projects involving compliance, mergers and acquisitions, and product licenses.
About Pharmalink
1. Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
2. They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
3. Case studies show Pharmalink's ability to successfully manage large, long-term global regulatory compliance projects for top pharmaceutical companies, ensuring on-time delivery and sustainable compliance.
About Pharmalink
This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses Pharmalink's capabilities and experience, including that it has over 155 staff and works with 18 of the top 20 healthcare companies. The document also presents 4 case studies of large regulatory projects Pharmalink has successfully completed for major pharmaceutical clients. These involved global compliance, product licensing, and mergers/acquisitions work. Finally, it notes Pharmalink's global regulatory expertise and additional translation capabilities.
About Pharmalink
- Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
- They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
- Case studies provided examples of large, long-term regulatory compliance projects Pharmalink successfully completed for major pharmaceutical companies, bringing hundreds of product licenses and dossiers into compliance through regulatory work.
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Prosoft Clinical
- 1. Prosoft Clinical Services and Capabilities 2012
- 3. Select List of Clients Product Experience Adoxa ® Tablets Klaron ® Lotion, 10% Retin-A MICRO ® microsphere, 0.1% and 0.04% Pump Atopiclair ® Nonsteroidal Cream Lovenox ® Sculptra ® Azmacort ® Inhalation Aerosol Nasacort ® Sculptra ® Aesthetic BenzaClin ® Topical Gel Noritate ® Cream, 1% Solaraze ® Gel Benzamycin ® Pak Penlac ® Nail Lacquer Topical Solution, 8% Taxotere ® Bystolic ® Propecia ® Tablets, 1 mg Zyclara ® Cream 2.5%, 3.75% (Packet and Pump) Carac ® Cream PSORCON ® E Emollient Ointment 0.05% Evolence ® Rilutek ®
- 6. Clinical Trial Experience Therapeutic Area Trials Phase Patients Services Allergy/Respiratory 20+ I – IV 3000+ Biostats, Data, Clinical Trial Mgt, CMC, Life Cycle Mgt, NDA, Nonclinical, Reg CNS 11 II, IV 500+ Adaptive Design, Biostats, Data, DMC, NDA, PMA, Reg Dermatology (Medical and Aesthetic) 20 I – IV* 2500+ ANDA, Biostats, Data, Clinical Trial Mgt, CMC, Life Cycle Mgt, Nonclinical, NDA, PMA, Reg Heart Failure (device) 1 III 200 Biostats, IDE HIV 3 I, III, IV 200+ Reg HIV diagnostics 6 II/III 600+ Biostats, Data Hypertension/ Cardiovascular 8 II/III 2500+ Biostats, Data, Clinical Trial Mgt, Reg Oncology 1 III 500 Biostats, DMC Pain (device) 2 II 100+ Biostats, Data, Reg Vaccine 6 I/II 400+ Biostats, DMC Women’s Health 1 II 200+ Biostats, Data, Clinical Trial Mgt, CMC, Life Cycle Mgt, Nonclinical, Reg
- 8. Contact Information: Dror Rom, Chairman and President Email: d.rom@prosoftclinical.com (p) 484-580-8162 x 302 Michael Nordsiek, CEO Email: m.nordsiek@prosoftclinical.com 484-580-8162 x 310 Ayala Rom, Director of Marketing Email: a.rom@prosoftclinical.com (p) 484-580-8162 x 314 Web: www.prosoftclinical.com