Existing Partners Part 2

MedSurgPI LLC

Strategic Consulting
Part time medical officers (Chief Medical Officer)

MedSurgPI+Logo
Key information
Type: Physician Consulting Group
Country: USA
Core activities:
  • Strategic Consulting
  • Part time Chief Medical Officer
  • Medical Monitors
  • Medical Affairs
  • Protocol Development
Website: www.medsurgpi.com
Proper Medical Writing Sp. z o.o.

Proper Medical Writing is a regulatory and medical writing consultancy founded in 2009, with a firm position in the Central European market. The company prides itself in a high intellectual capital, expertise, and experience resulting in excellent quality of its services.

PMW delivers clinical trial documentation, study design, statistical analysis, scientific translations, experts meetings, and trainings in a timely manner and at a competitive cost. It also specialises in the following: designing observational studies and patient registries; preparing formal documentation for drug safety and registration; and preparing and editing scientific texts, particularly scientific publications, and clinical data management. PMW covers all clinical areas, presenting an extensive portfolio in oncology, endocrinology, urology, pulmonology, cardiology, infectious diseases, and dermatology.

PMW’s knowledge of the medical field has inspired trust in many pharmaceutical/biotech companies, CROs, institutes, and scientific societies.

logo-PMW
Key information
Type: Regulatory and Medical Writing Consultancy
Country: Poland
Core activities:
  • Regulatory
  • Medical Writing
  • Training
  • Statistical Analysis
  • Medical Communication
Website: www.propermedicalwriting.com
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:

  • Recruitment and retention support (patient transportation, set-up of referral networks, expense reimbursement)
  • Sourcing of equipment and ancillary materials for clinical trials
  • Corporate Travel & Events Management (primarily for Clinical Trial and Pharma industry)
logo_IRM
Key information
Type: The Clinical Trial Service Company
Country: Ukraine
Core activities:
  • Patient Transportation
  • Equipment Sourcing
  • Organization of Investigators Meetings
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.

CF-logo
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.

bogomoletz
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.

RFF-Solutions_Logo
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.

IMG_6247
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
YourEncore

YourEncore delivers premier strategic and technical advisory services and solutions that mitigate risk, accelerate innovation, and drive growth in the life science industry.
We do this by mobilizing the wisdom and know-how of a world-class team of subject matter experts to deliver sage advice and hands-on execution.

Our experts are not your typical consultants. They are accomplished industry practitioners. They understand the hurdles you face, and they possess the strategic acumen you need to overcome them quickly and efficiently. By putting experience to work from strategy design to tactical execution, we are empowered to immediately deliver value to our clients and develop strategies for the future.
Guided by a leadership team representing more than a century’s worth of industry experience, our Centers of Excellence in Quality, Regulatory, Clinical, and Safety are designed to support our clients through the full development life cycle, delivering optimal results from every engagement.

YE_LOGO
Key information
Type: Strategic and Technical Advisory Consultancy in the Life Science Industry
Country: United States
Core activities:
  • Strategic and Technical Advisory Consulting in R&D
  • Quality
  • Regulatory
  • Clinical
  • Safety
Website: www.yourencore.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.

CCR_Logo
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
prolytic_logo
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/
partners_map

Find a partner in a certain geographic region using

The Interactive Partnership Map
Copyright © 2022 Pharmaxi LLC. All Rights Reserved.