Existing Partners 2

IRM LLC

IRM is The Clinical Trial Service Company that works with key industry stakeholders: Sponsors, CROs, Sites as well as global Functional Service Providers to deliver a successful Clinical Trial.

Company operations are focused on the areas of:

  • Equipment and Ancillary Materials Supply
  • Rental of medical equipment
  • Patient transportation management
  • Recruitment and retention support (set-up of referral networks, expense reimbursement)
  • Corporate Travel & Events Management (primarily for Clinical Trial and Pharma industry)
Key information
Type: The Clinical Trial Service Company
Country: Ukraine
Core activities:
  • Equipment and Ancillary Materials Supply
  • Rental of medical equipment
  • Patient transportation management
  • Recruitment and retention support (set-up of referral networks, expense reimbursement)
  • Corporate Travel & Events Management (primarily for Clinical Trial and Pharma industry)
Website: https://www.irm-europe.com
ClinFlows

ClinFlows offers regulatory compliant online solutions to manage the exchange of clinical data and medical images within various clinical projects. ClinFlows’ solutions support clinical trial workflows, product launch activities, clinical case reviews by medical experts (screening & eligibility) and central reads.

The decidemedical platform and ClinFlows’ www.dicomdrop.com application, enable all stakeholders of clinical workflows to share clinical cases quickly, easily and securely. ClinFlows simplifies the process of transferring large amount of medical images (DICOM) and clinical data between hospitals, institutes and specialist around the world, and facilitates collaboration on clinical cases through specific discussion and communication tools around medical images and clinical data.

ClinFlows customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes global healthcare companies. The decidemedical platform is utilised in 87 countries worldwide and allows GDPR compliance.

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Key information
Type: Provider of online solutions to exchange and submit clinical data and medical images.
Country: Germany
Core activities:
  • online medical image (DICOM) transfer tools
  • online image quality checks
  • online management of central reads
  • online case eligibility checks
  • online committee workflows
Website: www.clinflows.com and dicomdrop.com
Bogomoletz Institute of Physiology (BIPH)

BIPH is a scientific institution dedicated to biomedical research in the fields of physiology, biophysics, pathophysiology, neuroscience. It is a leading research center in Ukraine for neuroscience, electrophysiology and cardiovascular diseases.

Established more than 85 years ago by prominent scientist Alexander Bogomolets. Our institute has a big history of discoveries and inventions. Our major publications and expertise are in the field of biochemistry, genetics, molecular biology, neuroscience, medicine, pharmacology, toxicology and pharmaceutics. https://www.scopus.com/affil/profile.uri?afid=60068502

Now we work on regular basis with pharmaceuticals and high throughput screening in early drug discovery companies.

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Key information
Type: Self-governing state-funded organization
Country: Ukraine
Core activities:
  • All stages of preclinical research (from molecules to whole animals)
  • Drug testing
  • New compounds testing
  • Genetic analysis and gene knockout
  • Epigenetics analysis
Website: http://biph.kiev.ua
CRFF-Solutions

CRFF-Solutions is a cooperation of companies active in clinical research, covering all areas of clinical drug development. Emerging from classical phase I units, the cooperation extended phase I activities from male and female healthy young and elderly volunteers to target or special patient populations to serve as pharmacological models investigating the impact of impaired organ function on absorption, distribution, metabolization and excretion of investigational compounds.

CRFF-Solutions gained also experience in a variety of interaction trials including PK/PD correlation.
An exceptional recruitment and trial team building system guarantees high recruitment and retentions rates. The innovative recruitment system allows also to perform proof of concept trials and assist in multi-center phase IIb and III trials as rescue site provider.

Emerging from a highly standardized phase I unit, CRFF-Solutions transferred its concept of controlled boundary conditions to hospital based clinical sites, specialized in different therapeutic areas, for phase II and III clinical trials.

Key information
Type: Medium sized cooperation of SMOs and CROs with phase I units
Country: Germany
Core activities:
  • Phase I clinical trials in male and female young and elderly healthy subjects as well as in special populations (e.g. oncology patients, renal or hepatic impaired patients)
  • Phase I pharmacodynamic trials (e.g. TQT trials according to FDA standards in healthy subjects and risk populations (e.g. post-infarction patients)
  • Proof of concept trials in the target populations (phase IIa)
  • Clinical trial site selection and management for multi-center phase IIb and III trials
  • First experience in phase-less drug development by completing phase I and IIa activities in one protocol within less than six months
Website: https://crff-solutions.com
Leading Edge CDM Solutions, Inc.

Leading Edge CDM Solutions, Inc. (LeCDMS) is a unique consulting company dedicated to working with small and medium-sized biopharma and device companies with limited resources. We are experts in clinical trials end-to-end data delivering clinical data management, database builds, biostatistical and statistical programming services.

Our California-based company is staffed by (senior) professionals with many years of experience in building and managing US-based and international clinical trials. Since we have extensive experience in Clinical IT, the company is technology-agnostic – our studies utilize many of industry-standards EDCs. We conduct clinical trials of all sizes in all therapeutic areas with extended expertise in medical devices, cardiovascular space, neurology, pediatric, diagnostics and more…

We are uncompromising on conducting the highest quality clinical research and our agile structure and extensive partnership network allows us to address your budgetary challenges and deliver custom solutions tailored to you.

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Key information
Type: Small CRO
Country: USA
Core activities:
  • Clinical Data Management
  • EDC Programming
  • Biostatistical services
  • Statistical Programming
  • IT Clinical services
Website: www.LeadingEdgeCDMSolutions.com
Creative Clinical Research (CCR) GmbH

CCR is a Berlin based healthcare consulting and analytics firm with a focus on digitally driven innovation providing conventional as well as creative solutions to Pharmaceutical companies and CROs since 2011.

We provide premium medical scientific consulting, data management and statistical services in all phases of clinical drug development (Phase II-IV studies, NIS, PRO, POC, etc.) and also Providing ‘Out-of-the-box’ solutions to develop innovative areas for strategic expansion and automation.

Our team of highly experienced medical experts and statisticians have interdisciplinary knowledge in various therapeutic areas Oncology, Inflammatory Bowel Diseases, Diabetes mellitus, Anesthesia, Rheumatoid Arthritis and many more.

We are also developing very strongly into the area of advanced analytics and machine learning, having already developed predictive analytics for predicting adverse events and performing various exploratory analyses.

Our focus is equally divided into delivering innovative solutions and quality assurance, we have a very robust Quality Management System with >60 SOPs/ policies and an advanced IT infrastructure with CCR owned servers in datacenters in Germany and Finland. Please check our website for more details.

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Key information
Type: Healthcare consulting and Analytics (Small CRO)
Country: Germany
Core activities:
  • Medical Scientific Consulting
  • Medical Review
  • Statistics and Data Management
  • Statistics using Tableau BI
  • Creative solutions in clinical research such as automation of dossier development, Decision Tree for clinical data generation, etc.
Website: https://www.ccr-cro.com/
Prolytic GmbH

We are a German GLP/GCP laboratory for bioanalysis and pharmacokinetic evaluation. We provide our clients with the development and validation of analytical methods, analyse samples from pre-clinical, clinical and toxstudies, and also conduct compartmental and non-compartmental pharmacokinetic evaluation.

Our expertise are:

  • Bioanalysis for small and large molecules (LC/MS-MS and ELISA)
  • Pharmacokinetic evaluation with WinNonLin
  • RNA/DNA Analysis
  • Highest Quality through GLP/GCP certification
  • Over 25 years experience in drug development

We are your partner for:

  • Preclinical studies:
  • Dose-finding studies
  • Toxicological studies
  • Pharmacokinetic studies
  • Toxicokinetic studies
  • Clinical trials (Phases 0-III)
  • Bioequivalence/bioavailability studies
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Key information
Type: Bioanalytical Lab
Country: Germany
Core activities:
  • Bioanalysis
  • Pharmacokinetic Evaluation
  • LC-MS/MS, ELISA
  • miRNA Analysis
Website: https://www.prolytic.de/en/home-en/
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.

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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.
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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

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.

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