Source: https://www.acromion-gmbh.com/
Timestamp: 2019-04-21 10:44:21+00:00

Document:
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.
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 trial organization and conduct, clinical monitoring, clinical data management, statistics, quality assurance and medical writing for phase I to IV clinical and non-interventional (NIS) trials in the context of your projects.
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.
and reciprocal support is made for a most excellent study outcome.
Measuring and reporting progress in course of a trial 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 trial 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.
A team of highly skilled data managers will support all CDM-aspects of your project. Individual trial databases are developed according to your project’s requirements, validated prior to transfer to the production level.
Data analysts in the medical team are physicians with outstanding up-to-date competence and experience in data evaluation and data coding (using standard dictionaries such as MedDRA, WHO-DD or client specific dictionaries).
acromion is offering the implementation of a CDISC-ODM certified EDC system that integrates numerous functions from the areas of EDC, DDE, CDM, and ePRO in one application with centralized data storage. The system complies with all relevant GCP and FDA regulations, in particular with 21 CFR Part 11 offering a full audit trail, user and role management with electronic signatures, and multi-language eCRFs display (incl. Russian, Japanese).
The essentials of medical writing: comprehensible transfer of ideas or data into a trial protocol, report, documentation, or publication according to international standards and regulatory guidelines accomplishing a meaningful output of your trial concept or trial 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.
Clinical trials, ranging from simple to high complexity structure, are initiated and conducted, in a broad spectrum 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.
This fact reinforces GCP conform monitoring and source data verification of clinical data from your international clinical trials.
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.
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 trials.
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 learn about your needs and to provide customized services – whether you trust in us as full service provider or as enhancement of your existing resources.
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 considdering 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 trial at the optimal price-performance ratio.
Challenging projects demand proactive solutions, which are supervised and practically accompanied by project management.
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 trial 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.
Vendor audits to verify conformity of conditions, practices and processes to all relevant regulatory requirements.
Submitting trials to the regulatory bodies such as ethics committees and authorities can be challenging. Despite ongoing harmonization within the regulatory environment, there are still lots of local regulations and guidelines – and the regulatory submission process is fraught with potential obstacles. Submissions of clinical trials are time-intensive, time-consuming and cost-intensive. Against this background, a reliable partner with extensive regulatory experience is indispensable.
Our team of regulatory experts prepares – regardless of whether a conventional or an online submission is desired – the required packages and reviews (QC) all submission documents thoroughly to avoid the risk of delays due to incomplete or inaccurate regulatory 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.
Clinical trials, ranging from simple to high complexity structure, are initiated and conducted, in a broad spectrum 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.
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.
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.
Submitting trials to the regulatory bodies such as ethics committees and authorities can be challenging. Despite ongoing harmonization within the regulatory environment, there are still lots of local regulations and guidelines – and the regulatory submission process is fraught with potential obstacles.
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).
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.
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.
We are committed to deliver all services at high quality level according to our Standard Operating Procedures which have been developed according to international guidelines and recommendations.
We aim to create and maintain long-term relationships with our customers and within our team, based on mutual trust and respect.
We aim to create and maintain customer contentment. We want to establish successful, confident and steady collaborations based on our up-to-date know-how, experience and expertise.
We feel strongly responsible for our customers and their projects, as well as for the global scientific society we belong to, researchers and investigators, and of course our colleagues in the team.
We will bring in all our know-how, experience and expertise into each project to ensure its best possible outcome. Within our company management and employees will interact as partners. We are aware that for a service provider, people are the most important asset. Therefore we will ensure and maintain a working environment which allows responsible action and personal development.
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.
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.
The airport is 17.4 miles (28 km) away.
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).
Change at ‘Köln Weiden-West’ onto bus line 965 (direction ‘Frechen Grube Carl’) to stop ‘Frechen Briefzentrum’.
acromion@biokorea2018 It’s been an exciting pleasure to be in Seoul and meet up for updates, networking and sharing ideas. Thank you all and looking forward seeing you at the next opportunity!
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).
To carry out this project and to reach clinical translation, a consortium of nine partners from five different EU countries has been established. acromion GmbH is one of these nine partners.
4th Outsourcing in Clinical Trial East Asia conference.
It’s been an exciting pleasure to be in Seoul and meet up for updates, networking and sharing ideas.
Thank you all and looking forward seeing you at the next opportunity!
We take the protection of your data very seriously and want to ensure your safety when visiting our Internet page. We handle data protection, in particular, in compliance with the provisions of the European General Data Protection Regulation, the Federal Data Protection Act (BSDG – new) and the German Telemedia Act (TMG). We would herewith like to inform you of the nature, scope and purpose of the processing of your personal data. To begin with, we would like to point out that this Privacy Statement solely refers to our own web pages and does not apply to any third-party websites to which we may refer in the form of a link.
The object of this Privacy Statement is to protect personal data. This includes all information that refers to an identified or identifiable natural person – hereinafter referred to as the “data subject”. This includes, in particular, all information that allows conclusions to be drawn as to your identity (e.g. details such as your name, postal address, email address, IP address and telephone number).
In order for you to be able to set up a connection to our website, your browser transfers specific data to the webserver of our website. This is a technical requirement that allows the information you called up to be made available to you by our website. This is achieved by storing your IP address, the date and time of your request, your operating system type and other information which is then stored and used for a maximum period of 30 days. We reserve the right to store these data for a limited period in order to safeguard our legitimate interests so as to be able to derive information from personal data in the case of unauthorized access or the attempt to deliberately cause damage to our company through this route (Art. 6, para. 1 (f) GDPR). These data shall be solely stored or transferred for this and no other purpose, whereby we shall not inform you of this or ask for your consent in advance.
Cookies are small text files that are stored by your browser on your computer or mobile end device to detect, for example, whether you visit the same websites repeatedly from the same end device or browser. In general, we set cookies to analyze the interest in our website as well as to improve the user-friendliness of our website. In principle, however, you can also call up our website without using cookies.
As a rule, cookies can be deactivated or removed with the aid of special tools which are offered by most commercial browsers. For each browser that you use, you have to determine the settings separately and configure these individually. The different browsers offer a range of functions and options to this purpose.
When calling up our website, you will be informed about the use of these cookies by way of an informative text in our cookie banner. You automatically accept these cookies, if you continue to use them or by clicking on the “Ok” button.
The usage of session cookies allows users and the changes they make on a website to be identified. They allow the website to track their movements across individual pages so that information that has already been entered/stored does not have to be re-entered/stored again. Webshop shopping baskets are a good example of this. The session cookie stores the selected products in the shopping basket so that this contains the correct articles when payment is made at checkout. Session cookies are deleted when the user logs off or become invalid once the session has automatically expired.
A permanent or protocol cookie stores the user’s information and settings on the user’s computer for the duration of the period defined by the respective expiration date. This allows quicker and easier access as you do not, for example, have to repeat the language settings or re-enter your login data. These cookies are automatically deleted when the storage period expires.
As a rule, third party cookies have no influence on the usage of the page as they do not originate from the operator of the website. They fulfill, for example, the purpose of collecting information for advertising purposes, personalized content and web statistics and for passing these on to the respective third party provider.
Tracking cookies are special text files which open up the possibility of collecting data on the behavior of the Internet users. This is aimed at gaining information on what the user’s main points of interest are, for example, to be able to launch made-to-measure promotional offers. Therefore, tracking cookies are not only set during the login process but are automatically set whenever the website is visited.
The examples of the most common types of cookies in the above representation is intended to provide you with a global overview of this type of data collection. The information contained therein does not claim to be complete. As a result of technical developments in the IT sector, it is to be assumed that further cookie types will be developed during the course of time. Prior to using our website, please refer at regular intervals to the Privacy Statement on our website to find out about the latest changes.
Plugins from the LinkedIn social network of the LinkedIn Corporation, 2029 Stierlin Court, Mountain View, CA 94043, USA – hereinafter referred to as “LinkedIn” – are integrated into this website. These can be typically recognized by the LinkedIn logo (the letters “in” in white on a blue background) and the inclusion of text, such as, for example, “share”. Full details on the appearance of the LinkedIn plugin is available at: https://developer.linkedin.com/plugins LinkedIn logs information from the moment you call up our page and makes a connection between your browser and the LinkedIn servers. We, as the operator of the website, have no influence on the scope of the data or which data are transferred to LinkedIn through this plugin. According to Linked In, your logins, cookies, device information and IP addresses are used to identify you and log your usage. However, as soon as you click on one of the plugins, additional information is transferred which can directly link you to your LinkedIn account (in as far as you own such an account and are logged in). More information on this can be found in LinkedIn’s Privacy Statement at: https://www.linkedin.com/legal/privacy-policy.
We check this Privacy Statement on a regular basis to ensure that it complies with the legal provisions, the jurisprudence and the statements of the supervisory authorities, as well as to align it to emerging trends and the technological state of the art. In this respect, we reserve the right to change this Privacy Statement, in order to adjust this in line with new legal data protection requirements or other changes in the factual or legal circumstances. We kindly ask, therefore, that you always check the information on our Privacy Statement applicable at the time prior to using our website.
We treat your personal data confidentially and never pass these on to third parties unless you have provided us with your consent to do so or in cases where these are to be made available based on a legal or contractual commitment. In individual cases, we may contract processors to process your personal data. This would be carried out in accordance with Art. 28 GDPR and on the basis of a respective commissioned data processing contract.
The legislator has imposed numerous retention periods and deadlines.
Once these periods have lapsed, we delete the respective data as a matter of routine, in as far as they are no longer required with a view to fulfilling the contract. We store data that are processed based on your consent until this consent is revoked, resp. as long as these data are required. We store data that are processed based on a legitimate interest as long as this legitimate interest continues to exist.
In line with the legal provisions, commercial law data or financially-relevant data ensuing from a closed financial year are deleted after ten years, in as far as no longer retention periods have been stipulated or are required for legitimate reasons. In as far as the data are not subject to specific retention periods, they are deleted when the purpose for which they were processed ceases to exist.
We have already outlined the purposes and legal basis for processing data. In addition, the following generally applies: Where required, we process your data to safeguard our legitimate interests or those of other third parties in accordance with Art. 6, para. 1 (f) GDPR, for example to establish legal claims or to defend ourselves in legal disputes or to uphold our IT operations or security.
Only in cases where we have a legitimate interest or where we have received your written consent to process your personal data do we process your data for purposes of external communications and marketing on the basis of Art. 6, para. 1 (a) or (f) GDPR. You have the right to revoke your consent at any time.
To comply with legal obligations, we are allowed or must, where required, process your data and pass these on to third parties (in accordance with Art. 6, para. 1 (c)).
In no case shall we use your data in an automated decision-making process or for profiling purposes.
In accordance with Art. 15 GDPR, you have the right to receive information. This means that you can request confirmation from us as to whether your personal data are being processes by ourselves.
In accordance with Art. 16 GDPR, you have the right to rectification. This means that you can demand that we rectify any incorrect personal data concerning yourself.
In accordance with Art. 17 GDPR, you have the right to erasure (“right to be forgotten”). This means that you can demand that we erase any personal data concerning your person without undue delay – unless we are unable to erase your data due to being required to observe, for example, legal retention periods.
In accordance with Art. 18 GDPR, you have the right to restriction of processing. This means that we are practically no longer allowed to process your personal data – apart from storing them.
In accordance with Art. 20, GDPR, you have the right to data portability. This means that you have the right to receive the personal data concerning yourself and that you have made available to us in a structured, commonly used and machine-readable format and to transmit these data to another controller.
In accordance with Art. 7, para. 3 GDPR, you have the right to withdraw any consent you have provided at any time with future effect.
In accordance with Art. 13 GDPR, you have the right to lodge a complaint with the responsible supervisory authority.
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).
You have the right to object, on grounds resulting from your particular situation, at any time to the processing of personal data concerning your person which is carried out based on Art. 6, para. 1 (f) GDPR (data processing based on the weighing up of legitimate interests); this also applies to profiling based on this provision as described in Art. 4 (4) GDPR.
If you object, we will no longer process your personal data unless we can demonstrate compelling legitimate grounds for processing which override your interests, rights and freedoms or where this processing is for the establishment, exercise or defense of legal claims.
Please direct your objection in writing (via email or post) to the attention of our Data Protection Officer (see contact information listed above).

References: Art. 28
 Art. 6
 Art. 6
 Art. 6
 Art. 15
 Art. 16
 Art. 17
 Art. 18
 Art. 20
 Art. 7
 Art. 13
 Art. 6
 Art. 4