We are committed to quality and focus our capabilities to ensure that our services meet or exceed our customer's expectations. In compliance with highest professional standards, we continuously advance our quality management system, that defines the scope for improving our performance.
… scientific expertise for your objectives
acromion GmbH is a European, independent, privately owned, full-service Contract Research Organization (CRO) with years of experience in medical and bioscientific research. We support our customers in developing pharmaceuticals, biologics and medical devices, both for the human and the veterinary market. We provide full-service in study organization and conduct, clinical monitoring, clinical data management, statistics, quality assurance and medical writing for phase I to IV clinical and non-interventional (NIS) studies in the context of your projects.
… competency, transparency, accountability
Your team will benefit from the secure knowledge that we take responsibility for the accurate performance of all tasks that we are assigned to. Due to our long-standing capability in managing complex projects with many involved parties we identify upcoming issues and pro-actively present and initiate measures for improvement.
acromion is very experienced in conducting clinical studies as the leading member within a network of service providers. We are open in adopting the sponsor’s SOPs and in collaborating with already established partners. The work in such partnership is highly appreciated ensuring that common effort
and reciprocal support is made for a most excellent study outcome.
Measuring and reporting progress in course of a study is imperative. You can rely on being provided regularly on schedule and promptly on demand with information, and being alerted of all issues that require your attention.
Once assigned to a project our team is taking the responsibility for its successful outcome and the obligation to accuratelly report and explain all actions during its lifetime. You will find the peace of mind knowing that the A-team is in charge of your project.
The statistical department provides comprehensive consulting for all biometrical aspects of your clinical study be it a phase I to IV, post-marketing NIS, an epidemiologic study or a registry. Our senior biostatisticians have three decades of experience in clinical research and expertise in numerous therapeutic areas.
Statistical Planning
Analysis of data
Presentation of results
Additional Support
Our software in use
Phone: +49 (0)2234-20 37 37-17
Fax: +49 (0)2234-20 37 37-9
Your protocol is complex but you do not want to overwhelm your sites and investigators with overcomplicated technical requirements? You must have a validated, stable, user friendly, flexible eCRF? Including eCOA, eDiary, automated safety reporting? You expect high-quality, reliable, and statistically sound data from your study? This is where we can help!
A team of highly skilled Data Managers provides full support for all aspects of your study. Study specific databases are developed according to your project’s requirements. If requested, we deliver data in CDISC SDTM and CDISC ADAM format.
At acromion our preference leans towards web-based EDC systems, but we still can accommodate a validated paper CRF process.
Our Medical Data Analysts are physicians with outstanding up-to-date competence and experience in data validation and data coding (e.g., with MedDRA, WHO-DD or client specific dictionaries).
The complex variety of clinical studies is calling for customised and accurately tailored data management solutions. The acromion team analyses the specific needs of your individual project in depth offering the most suitable concept including the following services:
Phone: +49 (0)2234-20 37 37-28
Fax: +49 (0)2234-20 37 37-9
The essentials of medical writing: comprehensible transfer of ideas or data into a study protocol, report, documentation, or publication according to international standards and regulatory guidelines accomplishing a meaningful output of your study concept or study results.
Our medical writing team consists of physicians and natural scientists with long-standing experience in a wide range of medical and bioscientific areas. Gain from our years of expert editorial and writing experience, both, German and English.
Development of study concept and design, and compilation of study documents
Development of regulatory documents
Development of study output documents
English study documents will be translated according to local regulations, as required
Phone: +49 (0)2234-20 37 37-27
Fax: +49 (0)2234-20 37 37-9
Clinical studies, ranging from simple to high complexity structure, are initiated and conducted, in a broad spectrum of therapeutic indications.
Our team of educated and skilled clinical research associates has outstanding qualification and experience.
Our CRAs are managing investigative sites with personal interest and professional dedication.
Our monitoring activities include:
Key qualification factors for our monitoring team are:
This fact reinforces GCP conform monitoring and source data verification of clinical data from your international clinical studies.
Phone: +49 (0)2234-20 37 37-23
Fax: +49 (0)2234-20 37 37-9
Vigilance in safety surveillance in clinical research asks for particular attention
In close collaboration with our project management and – if needed – cooperation with a network of long-standing specialized partners, acromion´s medically qualified professionals provide support and assistance to the sponsor’s pharmacovigilance department.
Trust in us for:
For more information, please contact
Phone: +49 (0)2234-20 37 37-16
Fax: +49 (0)2234-20 37 37-9
acromion GmbH is a privately-owned Contract Research Organisation (CRO) offering full service in clinical development for the pharmaceutical, biotech, medical device industry, and investigator-initiated clinical studies.
Based on international scientific standards, we offer customized solutions for all steps along your clinical development program and medical research, from clinical trials phase I to phase IV, as well as for non-interventional studies and post-authorization safety or efficacy studies (PASS and PAES). In addition, we host various disease and product registries. Our operational team can substantiate decades of experience in clinical research. Gain from our expertise, ability and commitment to deliver services of excellent quality.
We are looking forward to learning about your needs and to provide customized services – whether you trust in us as full service provider or as enhancement of your existing resources.
Phase I
For more information, please contact
Phone: +49 (0)2234-20 37 37-23
Fax: +49 (0)2234-20 37 37-9
Phase II – IV / NIS
For more information, please contact
In acromion project management you will meet scientific specialists and experts in clinical research.
The best specialist in respect of your project will be the point of contact, and the project manager throughout the complete duration of our cooperation considering your individual project needs.
Our project managing teams are specialists in conceptual design, organisation and coordination of all activities. With high levels of experience, we are your adequate partner to efficiently plan and realize your clinical study at the optimal price-performance ratio.
Challenging projects demand proactive solutions, which are supervised and practically accompanied by project management.
From project start to completion you will be cooperating with your dedicated project manager who is responsible for:
Development of study plans:
Financial management with regard to:
Running project to contract
Project team support
Project completion and handover of the Trial Master File
Phone: +49 (0)2234-20 37 37-15
Fax: +49 (0)2234-20 37 37-9
The acromion Quality Management Department
Our main focus is the continuous advancement of our quality assurance activities and techniques. Diligent control and self-control ensure that all ethical and regulatory requirements defining the quality of a clinical study are fully met at all times and in all our operations.
To guarantee compliance with international quality standards, best practices and ethical principles for instance ICH – GCP (Good Clinical Practice) E6, other ICH guidelines (Quality, Efficacy, Safety, Multidisciplinary), EU Regulations, Code of Federal Regulation 21 (CFR 21) acromion has designed a well-structured Quality Management System. Our activities are regulated by internal SOPs which are an important part of the QM System. These SOPs are followed by all our employees as a matter of course: safeguarding compliance to regulatory requirements and guidelines.
Continuous training and regular participation at QA and other relevant conferences keep our QA personnel’s high competence up to date and top level.
Of course, our clients conduct audits on a regular basis. From the company’s beginnings in 2002 until today we have successfully passed every single external audit and all inspections without any critical or major findings.
acromion GmbH Quality Management Department offers:
Phone: +49 (0)2234-20 37 37-19
Fax: +49 (0)2234-20 37 37-9
Following the full entry into force of CTR 536/2014 and the launch of the CTIS portal on 30 January 2022, we now have the desired harmonization of the submission process for (the vast majority of) clinical trials to be conducted in the EU. The application – via the CTIS portal – is exciting and requires a comprehensive knowledge of the individual modules.
acromion has many years of experience in dealing with regulatory databases, regardless of the type of clinical study, and remains your reliable partner.
Our team of regulatory experts prepares – regardless of whether a CTIS, a conventional or an online application is desired – the required packages and reviews (QC) all application documents thoroughly to avoid the risk of delays due to incomplete or inaccurate applications. Our effective application and submission processes for clinical trials, medical device studies and non-interventional studies comply with all regulatory requirements. If ethics committees or authorities request clarification on certain aspects of a project, we offer any regulatory, medical or statistical counsel/support.
We are the reliable partner – for studies at both national and international levels.
Phone: +49 (0)2234-20 37 37-19
Fax: +49 (0)2234-20 37 37-9
Despina Topalidou
General Manager
Rainer Diehl
General Manager
Talking about „being different“: acromion GmbH proudly presents its team of highly qualified
specialists. For us “Human resources” are the heart of the matter. Therefore, we cherish the
long-term professional experience of our team as our most valued resource. Gain from the
profound knowledge of our employees in clinical research - physicians, statisticians,
pharmacologists, biologists and all-rounders - who will be glad to stand by your side.
Excellence: Meet our team and rely on their expertise in
a large variety of therapeutic areas
International scientific research needs multifold skills in international communication. Naturally, our staff is fluent in German and English. Furthermore, native speakers of Italian, Spanish, Danish, Swedish, Polish, Greek, Corean, Hungarian and Romanian rank among our team, and you may also rely on proficient skills in other European languages, e.g., French or Dutch.
Our employees offer substantial skills in various fields of medical and biological research and therapy. If you are interest in further information, please do not hesitate to contact us.
Therapeutic experience (for details please click the button)
Our credo is “contentment by successful collaboration”‚ and for us success is not primarily defined financially but rather sets contentment of customers and colleagues first.
From highway A1
Take the exit ‘Frechen’ at the highway crossing Cologne-West (A1/A4) and turn right on the B264 (Dürener Str.) direction ‘Frechen’.
Leave the B264 at the next traffic light and turn right on the Kölner Str. (L277). Turn right again at the 1st possibility (there are two right-turn lines, please use the left one), follow the road, pass around ‘Porta’ and turn left at the roundabout into ‘Europaallee’.
Follow ‘Europaallee’ to the next roundabout and then turn right. The office building is located 100 m further on the left hand side.
From airport Cologne/Bonn
The airport is 17.4 miles (28 km) away.
Take any city rail to Cologne central station ‘Köln Hbf’. Take from here S-Bahn (city rail) line 12 direction ‘Düren’ to stop ’Köln Weiden-West’. For detailed scheduled information please refer to: DB Bahn
From there you can take the bus no 965 (direction ‘Frechen Grube Carl’). The bus leaves every 30 minutes and takes about 10 minutes. Alternatively you may take a taxi (5 minutes).
From the city of Cologne
Tram line 7 (from city center direction ‘Frechen Benzelrath’) to the stop ‘Frechen Rathaus’; change at ‘Frechen Rathaus’ onto bus line 976 (direction ‘Frechen Briefzentrum’) or bus line 965 (direction Cologne ‘Weiden-West’) to the stop ‘Frechen Briefzentrum’
or
S-Bahn (city rail from the central station ‘Hbf’) lines 12 direction ‘Düren’ to ’Köln Weiden-West’
or
Tram line 1 (from city center to ‘Köln Weiden-West’) to terminal stop
Change at ‘Köln Weiden-West’ onto bus line 965 (direction ‘Frechen Grube Carl’) to stop ‘Frechen Briefzentrum’.
The annual SYMPOSIUM will take place on November 22, 2024, at the Holiday Inn Munich – City Centre
The annual SYMPOSIUM will take place on November 24, 2023, at the Holiday Inn Munich – City Centre
It’s been a pleasure for acromion to participate in BioKorea 2023, sharing knowledge, stimulating new ways of shared interests and contributing to shifting global clinical drug development forward. Looking forward to stay in touch!
It is our pleasure to be sponsor and support this conference sharing the latest advances in biology, clinical research, diagnostics and treatment of Hodgkin Lymphoma.
38. Jahreskongress Pharmazeutische Medizin in Düsseldorf
The annual SYMPOSIUM will take place on November 25, 2022, in the Westin Grand Hotel in Munich
The annual SYMPOSIUM will take place on November 26, 2021, in the Service Congress Center (SCC) in Munich
A day to celebrate our achievements and successes and a day to appreciate our colleagues and employees for their dedication and efforts, and our partners for their support, and our customers for their trust and encouragement.
BIO Deutschland und der Arbeitskreis der BioRegionen veranstalten seit 2010 die jährlichen, zweitägigen Deutschen Biotechnologietage (DBT) als Forum für den Erfahrungsaustausch zwischen allen Akteuren der deutschen Biotechnologieszene.
36. Jahreskongress Pharmazeutische Medizin in Berlin
5th European Conference of Clinical Research in Amsterdam
Acromion is attending the EUCROF conference.
The European funded projects CARAMBA and EURE-CART are organising a joint CAR-T Regulatory Workshop on Jan 30th 2020, right before the 2nd CAR-T cell meeting (Sitges).
This open workshop will be a great opportunity to share experiences gained during CARAMBA and EURE-CART and discuss key regulatory aspects of the CAR-T cell product, against the background of different national regulations on GMOs.
The annual SYMPOSIUM will take place on November 29, 2019, in the Sheraton Arabellapark Hotel in Munich
The European Union has awarded EURE-CART (EURopean Endeavour for Chimeric Antigen Repector Therapies) with 5 Million Euro within the Horizon 2020 – Research and Innovation Framework Programme, section reserved to the new therapies for chronic diseases (including cancer).
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Darüber hinaus steht Ihnen ein Widerspruchsrecht zu, dass wir im nachfolgenden grauen Kasten genauer erläutern.
Wenn Sie von Ihren Rechten Gebrauch machen wollen, wenden Sie sich bitte an den Datenschutzbeauftragten (Kontaktdaten siehe oben). Zuständige AufsichtsbehördeName | Source | Function | Validity |
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In addition, you also have the right to object which we will be explaining in more detail at the end of this data protection information sheet.
If you would like to exercise any of your above rights, please contact our Data Protection Officer (see contact information listed above). Responsible supervisory authorityName and address
acromion GmbH
Europaallee 27-29
D-50226 Frechen
General Management
Despina Topalidou
Rainer Diehl
Telephone/Telefax number
Tel: +49 (0)2234-20 37 37-0
Fax: +49 (0)2234-20 37 37-9
Email address
info@acromion-gmbh.com
Registrations
Registergericht: Amtsgericht Köln HRB 45379
VAT ID No
DE224978890
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