Holochem is a customer-oriented CRO offering chemistry manufacturing and control services for the development of fine chemicals and drug substances for the pharmaceutical chemistry, animal health, cosmetics and agro-sciences industries. Holochem provides R&D services for the development of small and complex molecules, key intermediates, and APIs, highly potent APIs & ADC linkers, impurities, metabolites and reference standards. We produce non-GMP pre-clinical batches from milligram to kilo-scale for early-phase formulation and toxicological use.
NoyMed is a contract research organization (CRO) specializing in Biometrics services. We offer expert Biostatistics, Statistical Programming, CDISC Implementation, Data Migration, and Clinical Data Management services to pharmaceutical, biotechnology and medical device companies worldwide. We are an approved vendor for a huge number of pharmaceutical, biotech companies and CROs globally working on different outsourcing models.
Our team has more than 10 years of experience in almost all therapeutic areas and in various phases of clinical development. We have experience working with different EDC systems e.g Medidata Rave, OpenClinica, Medrio, Oracle InForm etc. We support studies from study startup to closeout preparing final FDA, EMA submission ready packages.
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.
Finklyn is a site payment provider that enables efficient invoice and payment management in clinical trials.
Our digital platform supports you in achieving your goals and regain focus on your core activities:
PHARMAPOINT S. A. is a part of Pelion Healthcare Group as a part of the wholesale business line provides clinical trials logistics services including: market research; documentation gathering and analysis; product sourcing and acquisition; product storage including ambient and cold chain stock in accordance with GDP; logistic and distribution support; product kitting, labelling and repacking.
The range of services is constantly enlargened and adjusted to changing market conditions. We are open to new forms of cooperation and continually analyze trends on the pharmaceutical market to meet the expectations of our business partners.
ARENSIA has its own network of nine state of the art exploratory medicine units with full Phase I / II / PROOF OF CONCEPT patient capabilities. These modern units are located within dedicated areas in prestigious University Hospitals in Romania, Republic of Moldova, Georgia, and Ukraine.
ARENSIA has been building deep relationships with each of the hospitals where our units reside. This has allowed ARENSIA to achieve industry leading recruitment rates across a number of therapeutic areas, whilst still maintaining the highest resulting data quality.
Trialsquare is a company that designed and developed a cloud-based Content Management System (CMS) dedicated for the management of controlled documents in the life science industry, namely the electronic Trial Master File (eTMF) and the electronic Investigator Site File (eISF). Trialsquare’s eTMF-eISF is aimed at the pharmaceutical, biotechnology and medical device companies, as well as Contract Research Organisations, Ethics Committees and leading academic institutions involved in clinical development.
Trialsquare’s eTMF-eISF provides users with a completely secure environment and set of tools, allowing them to manage essential documents required for the Trial Management File. At the same time, it enables access to documents and information in real-time, enhancing collaboration between key members of the project, from Sponsors to Sites.
The Trialsquare application was designed and implemented according to industry standards and applicable regulatory requirements, including: EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, GCP E6 R2 and TMF Reference Model.
Rephine is a global pharmaceutical consultancy founded in 1998 that focuses on GCP and GMP compliance, as well as regulatory matters. Rephine has an extensive library of over 190 GMP audit reports that covers 7,390 individual products which makes Rephine the largest provider of third-party GMP audit reports in Europe.
Rephine GXP consultants are a global group of highly professional and experienced personnel who have worked with multinational pharmaceutical organisations and CROs able to provide outstanding GCP and GMP service at very competitive price schemes. Rephine provides first class pharmaceutical manufacturing consultancy, QP Services and Due Diligence services and a full range of GCP services.
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.
At Pharma Professionals we have developed capabilities to support clinical trials
with home-care services that help enhance the quality of patients’ lives while
maximizing recruitment and retention for our clients.
Our GCP-trained personnel visit patients at their homes or work and are responsible for activities including sample collection, vital signs documentation, study-drug administration, monitoring changes in patient health, and visit documentation.
We also deliver a wide range of staffing solutions to Pharmaceutical,
Biotechnology, and Clinical Research Organisations as well as Medical Device and
Diagnostics companies across Europe.
We recruit professionals who work with human as well as animal-health products, including pharmaceuticals, vaccines and biologics in addition to consumer health products.
We serve both innovative and generic clients. We work with both corporate organizations listed among top 50 global pharmaceutical and biotechnology companies as well as with midsized and small life-science companies.
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
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