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.
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.
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.
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).
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).
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
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.
With 15 years of experience, Proper Medical Writing is Poland’s most established medical communication agency, supporting academia and the pharmaceutical industry.
Our services include biomedical data presentation, medical and regulatory writing, alongside consultancy and tailored training.
Clients trust us for quality, security, and efficient use of resources.
We emphasize experience, expertise, and ongoing education to deliver innovative solutions for every project.
Analytical Center Biopharm GmbH is a GLP- and GMP-certified, GCP- and FDA-inspected Contract Research Organization (CRO) with over 20 years of experience in bioanalytical and pharmaceutical analytics for human and veterinary drug products.
Our services include:
We pride ourselves on:
Choose Biopharm for high-quality analytics and expert support.
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.
