Existing Partners Part 4

Estimondo GmbH

Estimondo is an independent provider of expert services in the areas of statistics and statistical programming for the healthcare industry. Our service portfolio covers biostatistical writing, programming, analysis, consulting and training services. We are there for the entire lifecycle of clinical studies from planning via conduct, analysis and reporting to publication of data-centric projects.
Experienced in many therapeutic areas and across all clinical phases, our innovative metadata-based analysis and reporting system allows fast and reliable production of biostatistics deliverables such as ADaM datasets, tables, listings, figures, and reports, all accompanied by full documentation including statistical analysis plans, statistical programming specifications, TFL shells, ADaM specifications, define.xml, ADRG, source codes and log files.
Our services are tailored to client needs by flexible metadata definitions, provided by qualified experienced associates and managed by central one-contact biostatistics project management provided by Estimondo.

Key information
Type: Biostatistics Service Provider
Country: Germany
Core activities:
  • Biostatistical Analysis
  • Statistical Programming Services
  • Statistical Writing Services
  • Statistical Consulting
  • Biostatistics Training
Website: www.estimondo.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.

Key information
Type: Regulatory and Medical Writing Consultancy
Country: Poland
Core activities:
  • Regulatory
  • Medical Writing
  • Training
  • Statistical Analysis
  • Medical Communication
Website: www.propermedicalwriting.com
Analytisches Zentrum Biopharm GmbH Berlin (AZ-Biopharm)

Analytical Center Biopharm GmbH is a GLP and GMP certified testing facility (CRO) with many years of experience in bioanalytical and pharmaceutical testing of human and veterinary drugs. We determine the identity, content and purity of active substances and drug products, and performing residue analysis in edible farm animal tissues, stability testing and physicochemical analysis of intermediates according to the Chemicals Act. Under GLP/GCP we determine the drug concentration and, where applicable, their metabolites in biological matrix in BE-, pharmacokinetic and bioavailability preclinical and clinical studies using state-of-the-art analytical techniques

We offer

  • Tailored solutions and individual offers
  • Qualified GLP/GCP and GMP-compliant analytics
  • Competent and speedy advice and project processing
  • Comprehensive reporting in German and / or English
  • A high quality standard
  • Qualified / validated test equipment, which meets the requirements of 21 CFR Part 11

Key information
Type: medium CRS, Bioanalytical lab, QC lab
Country: Germany
Core activities:
  • BE studies of small and large molecules
  • Bioanalytics of PK and TK studies
  • Method development and validation according to FDA and EMA guidelines
  • QC of raw material, excipients and finished products
  • Stability testing acc. ICH also for controlled substances
Website: https://www.az-biopharm.de/
Dar Clinical Research Inc.

DAR is a unique Site Management Organization (SMO) dedicated to providing clinical trial related services to Investigators and Clinical Research Sites.

Our service models are designed specifically to our client’s needs. Our function is to help create, maintain, or manage innovative clinical trial sites by providing a full range of services, thus allowing Investigators to focus on quality, reliability, safety, trust, transparency, and communication regarding trials within our community.

In the process, we help build a trusted and experienced research professional teams to carry-out the clinical trial responsibilities and provide quality data to sponsors to meet their objectives and metrics.

Key information
Type: Site Management Organization
Country: Canada
Core activities:
  • Operational Management
  • Quality Assurance
  • Recruitment Strategies
  • Resource Oversight
Website: https://Darclinicalresearch.com

Since 1994 MZD is valued as long-lasting and reliable partner in providing clinical research professionals for clinical trials for the pharmaceutical, medical device & biotech industry. With a steadily expanding network of highly qualified freelance clinical research professionals MZD is specialized in project based staffing solutions for phases I through IV.

MZD also offers recruitment support for permanent staffing vacancies where we search for highly qualified and motivated professionals and executive staff.

Key information
Type: Freelance Clinical staffing
Country: Germany, world wide operating
Core activities:
  • CRA’s
  • Data managers
  • Clinical consultants
  • Freelancers
Website: www.clinicalresearchprofessionals.eu
Regulatory and Quality Solutions LLC

Regulatory and Quality Solutions, LLC (“R&Q”), is an ISO 9001:2015 certified consulting firm that provides comprehensive global regulatory affairs and quality assurance expert implementation services to the Medical Device Industry.

R&Q has advised more than 250 clients across more than 1,000 projects with a diverse array of service offerings including, but not limited to: regulatory affairs, quality systems, clinical evaluations, design assurance, product quality, large remediations, and post-market surveillance.
R&Q has successfully partnered with clients of all sizes, from startups to large multinational firms, and across all modalities and classes of medical devices - nationally and internationally. R&Q has emerged as a partner to 13 of the top 20 global medical device companies by offering business balanced solutions to solve complex quality and regulatory issues in areas such as FDA medical device regulations, EU MDR, MEDDEV 2.7/1 Rev 4, ISO 13485:2016, and MDSAP.

Key information
Type: Regulatory Affairs and Quality System Consulting
Country: The USA
Core activities:
  • World-wide Regulatory Affairs
  • Clinical Evaluation Reports
  • Quality Systems
  • Post Market Surveillance
  • Design Assurance
Website: www.rqteam.com

Analytical Department at BLIRT S.A. offers an integrated portfolio of GLP/GMP-certified analytical and bioanalytical services for all stages of the drug development process – from preclinical (ADME) studies, through bioequivalence (BE) and pharmacokinetics (PK) for clinical trials (including statistical calculations) up to supporting drug registration, production and routine quality control of final products.

Bioanalytical laboratory offers GLP-certified services of qualitative and quantitative determination of drug and/or it’s active metabolite/s in human or animal matrices such as: plasma, whole blood, tissues etc.

Analyses of small molecules are performed mostly using high performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). Biomolecules determinations are focused mostly on immunoassays (ELISA.

Analyses meet the requirements of the relevant regulatory agencies responsible for the drug registration process.

Key information
Type: Bioanalytical Laboratory
Country: Poland
Core activities:
  • Pharmacokinetics and bioequivalence studies
  • Consultations regarding design of clinical trial
  • Development and validation of bioanalytical methods
  • Transfer or cross-validation of bioanalytical methods delivered by Sponsor
  • Sample preparation and sample analysis
Website: http://www.analytics.blirt.eu

Created in 1990, Strategie Sante is an independent French company providing Assistance and Advisory services to Pharmaceutical Laboratories with full confidentiality.

Thanks to our proven expertise in Regulatory Affairs, Pharmaceutical Development, Project Management, Medical Devices, Quality/Audits and Market Access, we support our clients throughout all steps of the conception and lifecycle of their products ensuring a complete quality service.

Key information
Type: Pharmaceutical Projects Management
Country: France
Core activities:
  • Regulatory Pharmaceutical and Medical devices
  • Pharmaceutical development
  • Project Management
  • Quality and Audits
  • Market Access
Website: www.strategiesante.com

MedPharm is the world’s leading contract provider of topical and transdermal product design and formulation development services. MedPharm is experts at reducing risk and accelerating development times for generic and proprietary pharmaceutical customers through their unique, cost-effective and industry-leading performance testing models.

Well established as the global leaders in dermatology, nail, mucosal membrane, and transdermal product development, MedPharm can also offer innovative solutions for ophthalmic and airway preparations recognised for their scientific rigour by regulators and investors. MedPharm has fully established Centers of Excellence in the USA and the UK.

Key information
Type: CDMO
Country: United Kingdom
Core activities:
  • Formulation Development
  • Performance testing
  • GMP manufacture
  • Analytical and Bioanalytical methods
  • Reverse engineering and preliminary process assessment
Website: www.medpharm.com

ancillarie is a support services company established in 2012. Company provides services in Biostatistics, Clinical Data Management, Medical Writing, Pharmacovigilance, Resourcing and Quality Assurance services for Pharmaceutical, Biotechnology and Contract Research Organizations and helps them to accomplish their goal.

Ancillarie_ Logo
Key information
Type: Support Service Company
Country: India and Canada
Core activities:
  • Biostatistics
  • Clinical Data Management
  • Medical Writing
  • Pharmacovigilance and Quality Assurance
Website: www.ancillarie.com

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