Existing Partners Part 3

PGF Pharma International

PGF Pharma International is an EU based company, located in Croatia, that is specialized in Good manufacturing practice (GMP), R&D, regulatory and pharmacovigilance consulting. We offer a wide range of services, whereby providing your company with top level knowledge on EU regulations and procedures. With our know-how, we assure you reach the desired milestone in the shortest period possible and implement the highest pharmaceutical quality standards.

Key information
Type: Small CRO, Medium CRO, Bioanalytical Lab, Bioinformatics, GMP Consulting Company
Country: Croatia (EU)
Core activities:
  • Good manufacturing practice (GMP) consultancy
  • Pharmaceutical development projects
  • Regulatory strategies, registration and product lifecycle management
  • Pharmacovigilance
  • Medical writing & information management
Website: www.pgf.hr
NMI TT Pharmaservices

NMI TT Pharmaservices is a contract research provider specialized in protein profiling services. Founded in 2002, the company has accumulated a long-standing track record with numerous international pharma and biotechs.

Together with its parent institution NMI, a private research foundation, protein assay services for PK/PD markers are provided on the research level, and, for certain technologies, under GCP conditions.

Another focus is on bioanalytics services under GMP. In particular, the following assay services are offered:

  • Luminex protein assays (e.g. multiplex cytokine panels),
  • Simoa ultra-sensitive protein biomarker assays,
  • DigiWest and RPPA multiplex biomarker and pathway activity assays,
  • Custom immunoassay development, validation and screening,
  • Bioanalytics for pharmaceutical product QC, with GMP accreditation.
Key information
Type: Bioanalytical Lab
Country: Germany
Core activities:
  • Luminex protein assays (e.g. multiplex cytokine panels)
  • Simoa ultra-sensitive protein biomarker assays
  • DigiWest and RPPA multiplex biomarker and pathway activity assays
  • Custom immunoassay development, validation and screening
  • Bioanalytics for pharmaceutical product QC, with GMP accreditation.
Website: https://www.nmi-tt.de/pharmaservices/

Sply collaborates with pharmaceutical and biotech companies to support their clinical trial supply projects with its software application, Simply.

Simply is a clinical supply forecasting solution that lets clinical supply professionals manage their portfolio of supply packaging and distribution projects. Simply empowers you to reduce costs and to better manage clinical supply and packaging/distribution-related services by forecasting the trial product demand to create robust packaging and distribution plans.

Key information
Type: IT company and consultancy
Country: Denmark
Core activities:
  • Clinical trial supply forecasting
  • Operational clinical trial supply consultancy
Website: www.sply.dk

ClinConsent, a Saas eConsent tool to transform the informed Consent Process.

ClinConsent removes the risk of mishandled Consent documents and subsequent issues in regulatory inspections. It simplifies the informed consent for sponsors, Site managers, IRB, and Ethics Committees with an easy-to-use technology platform. This dramatically improves the visibility and transparency of the Consent process and leads to improved compliance.

A versatile product that can be used on most devices and across different platforms. Simple, user-friendly Electronic Consent. Patient-centric design keeps engagement and adherence up, while site staff is freed from time-consuming explanations and able to focus on higher value patient-focused efforts.

Key information
Type: Life Sciences and Health Care Technology Company
Country: India
Core activities:
  • Informed Consent Design and Development using ClinConsent platform
  • eConsent Multimedia design
  • eConsent Graphics design
  • eConsent Translational service
  • eConsent Helpdesk
Website: https://www.clinconsent.com

Want to get your clinical trials designed, built & submitted faster?

Now you can, with our off-the-shelf clinical metadata repository (MDR) and clinical trial automation platform. We’ve taken away those time-consuming and expensive manual tasks - from study set up to submission.

Our clinical MDR provides a central home for your organizational standards. Here you can manage, update, approve and reuse organizational standards. Whilst also keeping up with CDISC versions, and complying with regulatory requirements. You can even share and reuse content across different EDC and e-clinical systems.

And if you need help automating study design and build, we can do that too. Our clinical trial automation tools use the content in your MDR to build your studies much faster. Whether you want to design eCRFs, build EDCs, design or convert datasets, or make define files… Formedix helps you do it in a fraction of the time. Quick and painless.

Key information
Type: Clinical study automation software provider
Country: Scotland, UK
Core activities:
  • Clinical metadata repository (MDR)
  • Standards lifecycle management
  • eCRF design
  • Dataset design
  • SDTM dataset conversion
Website: https://www.formedix.com/
Onorach Ltd

Onorach Clinical manage Phase I to IV clinical research studies covering ALL therapeutic areas for drug, medical service, stem cell research, biomarkers.

Onorach also provide similar clinical trial services for Food Studies / Nutraceuticals/ Plant based pharma studies for medicines.

Onorach has experience with EMA, FDA and EFSA. We work internationally on clinical trials and use our three CROs in Scotland, Latvia and Lithuania.

Key information
Type: SME
Country: Main Office - Scotland. Subsidiaries - Latvia, Lithuania.
Core activities:
  • Project Management
  • Study Monitoring
  • Site Management
  • Regulatory and Quality Management
  • Medical Report Writing
Website: www.onorach.com
Institute for Implant Technology and Biomaterials e.V.

The Test Laboratory for Cardio+Vascular Products is an independent and autonomous laboratory integrated into the IIB. Its focus is physical testing of balloon catheters and stent systems used for the treatment of coronary artery disease and other vascular ailments.

The essential tests are subject to international standards (e.g. DIN EN ISO 25539-2), are established as standard operating procedures in the test laboratory and are used as validated tests for product approval in accordance with the terms of the Medical Devices Regulation (EU) 2017/745 (MDR). In addition, we also provide comparative tests of commercially available products, which can be helpful for scientific understanding of product function, for design verification, for market research and formulation of development goals of manufacturers. To respond to new demands of modern implants that are now emerging out of today‘s very reasonable safety and efficacy requirements, new innovative testing processes are being developed in close cooperation with our partners at the University of Rostock and our customers, which can then be offered as standardized tests.

Key information
Type: Accreditated testing laboratory – physical testing of medical devices
Country: Germany
Core activities:
  • Physical testing of cardiovascular and vascular devices and accessories (dimensions, mechanical behavior, surface inspection, particulate matter)
  • Testing for product approval using accredited test methods
  • Benchmark testing of prototypes compared to commercially available devices
  • Development of test methods for new devices
Website: www.iib-ev.de/en/testing-laboratory/
BioResearch Group Sp. z o. o.

BioResearch Group is a dedicated clinical site conducting early phase clinical trials as well as bioequivalence and bioavailability studies for biotech, pharma and CRO companies.

Our high quality service covers a wide range of medical, laboratory and pharmaceutical procedures, as well as administration and management of the study performed. We provide full clinical trial services from protocol design, study start-up, conduct and final study report preparation. Our team is a challenge-oriented, highly engaged, motivated and specialised in phase 1 clinical trials.

BioResearch Group has a dedicated space within the hospital premises exclusively for conducting early phase trials. This includes clinics for consultants to see patients, sample collection room, data entry room or drug storage.

Our high quality of services is confirmed by GCLP accreditation by Qualogy Ltd (No 06019).

Key information
Type: Clinical Site
Country: Poland
Core activities:
  • Clinical study conduct
  • Data Management
  • Medical writing
  • GCP trainings
Website: www.bioresearch.pl
ACOMED statistik

ACOMED statistik is a service provider for statistical design and analysis in clinical research. Pharmaceutical, medical device and diagnostic industry as well as CRO and university research groups belong to the customers of ACOMED statistik.

ACOMED statistik was founded in 2003 by Dr. Thomas Keller. We are now working as a team of 3 statisticians. The following services are provided by ACOMED statistik:
- concept of the study
- involved in synopsis of the study protocol and in the full study protocol (endpoints, statistical methods, sample size, review)
- Statistical analysis plan
- SAS-programming and SAS-output of tables, lists and figures
- blinded data review and other study meetings
- Discussion of results with sponsor and investigators
- Statistical report, parts of clinical study report
- medical writing (publications)

The services are provided within the framework of a quality management system (quality manual, SOPS, templates).

Key information
Type: Clinical Site
Country: Germany
Core activities:
  • Statistical consulting, design and analysis for clinical trials
  • Statistical design and analysis for analytical performance evaluations of in vitro diagnostics
  • Statistical design and analysis for clinical perfomance evaluation of medical devices and in vitro diagnostics (Diagnostic studies)
  • SAS-programming
  • Statistical training and seminars
Website: https://www.acomed-statistik.de
Medwave Medical Imaging

Medwave Medical Imaging is specialized in end-to-end medical imaging solutions ranging from protocol development, image collection and processing to the organization and conduct of central image reviews.

Medwave Medical Imaging is specialised in central imaging reviews for oncology studies

Key information
Type: Small dedicated Imaging CRO specialized in oncology
Country: The Netherlands
Core activities:
  • Imaging workflow management
  • Set-up IT infrastucture for imaging repository and central imaging reviews
  • Development imaging review charters
  • International network of radiologists
  • Involved in several glioblastoma study with novel read methodoloies to discriminate between pseudoprogression and true progression
Website: http://www.medwave.nl
Guardian Research Network

Guardian Research Network is an oncology focused mission-driven consortium impacting clinical development and improving patient access to targeted and novel therapies.

We partner with high performing integrated hospital systems using our breakthrough platform. It enables access to big data and both molecular and clinical patient profiles and subsequently matches “in real time” to trials while empowering researchers for improved clinical development.

Guardian Research Network harnesses the power of big data to aggregate hundreds of thousands of cancer patients’ electronic medical records from multiple integrated community health systems into a single, searchable database, resulting in actionable data.

Key information
Type: Data Technology company
Country: The United States
Core activities:
  • Data analytics
  • Protocol optimization
  • Patient identification and patient recruitment
  • Clinical trial insights and support
Website: https://www.guardianresearch.org/

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