Phone: +49 (0)2234-20 37 37-0
E-Mail: info@acromion-gmbh.com
The acromion GmbH
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
… 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.
Why acromion?
… competency, transparency, accountability
Competency
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.
Transparency
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.
Accountability
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.
Services
Biometrics
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
- Elaboration of most suitable clinical study design
- Adaptive study design
- Sample size calculation and justification
- Development of statistical sections of the protocol
- Development of randomization schedule
- Expert Review of study documents
- Development of Statistical Analysis Plan
Analysis of data
- Conduct of Data Review Meetings
- Design, programming, and quality control of data displays (TLFs)
- Confirmatory and exploratory analysis
- Interim analysis and sample size adaptation
- Meta-Analysis and data mining
Presentation of results
- Development of statistical reports
- Development of statistical sections of integrated clinical study reports
- Publications
- Presentation of clinical study results
- CDISC compliant data transfer
Additional Support
- Consultancy
- Communication with regulatory authorities
- Statistical support for Data Monitoring Board
- Integrated summary of safety (ISS)
- Integrated summary of efficacy (ISE)
- Common technical document (CTD)
Our software in use
- SAS®
- nQuery®
- R software
Werner Baurecht
Head of Biometrics
Head of Biometrics
Phone: +49 (0)2234-20 37 37-17
Fax: +49 (0)2234-20 37 37-9
Clinical Data Management
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:
- Data Management and Data Validation Plan
- eCRF design, implementation, and validation (User Acceptance Test)
- Implementation of ePROs/eDiary and reminders in multiple languages
- e-validation of ePROs in multiple languages
- Data coding by medical data analysts (e.g. MedDRA, WHO-DD and/or sponsor specific coding dictionaries)
- Data cleaning, validation, and query management by Medical Data Analysts
- Electronic and manual query generation
- Medical data review
- Automated, electronic SAE reporting including eCRF data (email with PDF attachment with marked changes for follow-up reports)
- Online standard and customized reports, data listings and graphs
- Grant payment management
- Data import, e.g., laboratory or central reading data
- Data export to your final storage destination
- CDM compliance to CDISC-Standards (e.g. ODM, SDTM, Controlled Terminology)
- Electronic data transfers (e.g. csv, Excel, SAS, SDTM including define.xml, ODM xml)
- Reconciliation of various data sources (e.g. SAE reconciliation against safety database)
Stefan Hermann
Senior Data Manager
Senior Data Manager
Phone: +49 (0)2234-20 37 37-28
Fax: +49 (0)2234-20 37 37-9
Medical Writing
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
- Trial protocol, CIP, observational plan, synopses, and amendments/modifications
- Patient Information form and leaflet
- Informed consent form
- Case report forms, patient diaries, and questionnaires (paper and electronical)
- Translation of study documents for national use according to local regulatory requirements
Development of regulatory documents
- Investigator´s Brochure (IB)
- Investigational Medicinal Product Dossier (IMPD)
Development of study output documents
- Integrated clinical study reports (and e.g. ´mock´ or ´shell`, Interim, and abbreviated reports)
- Relevant parts of the Common Technical Document (CTD)
- Scientific publications, abstracts, posters, and presentations
English study documents will be translated according to local regulations, as required
Michael Braun
Head of Medical Writing
Head of Medical Writing
Phone: +49 (0)2234-20 37 37-27
Fax: +49 (0)2234-20 37 37-9
Monitoring
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:
- Identification and assessment of potential sites
- Supporting technologies:
to enhance the process of clinical site evaluation and local feasibility assessment (eSPA) - Collection and processing of essential documents
- Preparation and conduct of initiation visits
- Review and presentation of study material
- Training of site personnel and motivation of investigative staff
- Preparation and conduct of periodic monitoring visits
- Control of protocol compliance
- CRF-check and SDV
- Monitoring of timely and complete SAE/AE reporting
- Support in query resolution
- Control of drug accountability, drug and non-drug supplies
- Review and maintenance of investigator files
- Audit preparation of trial sites and resolution of audit findings
- Documentation of all activities
- Processing and administration of investigator payments
- Preparation and conduct of close-out visits
Key qualification factors for our monitoring team are:
- Profound experience in clinical research
- Intent accuracy and focused attention to details
- Strong communication abilities
- Highly developed organisational skills
- Enthusiasm
- Profound computer skills
- Preparedness for on-site presence for a specified period of time
- Fluent in German and English and often a third language- e.g. French, Italian, Dutch, Spanish, Polish, Greek, Hungarian, Romanian, Corean – with profund skill in medical terminology
This fact reinforces GCP conform monitoring and source data verification of clinical data from your international clinical studies.
Julita Kelm-Wozniak
CRA Manager
CRA Manager
Phone: +49 (0)2234-20 37 37-23
Fax: +49 (0)2234-20 37 37-9
Safety Surveillance
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:
- Development of trial specific safety plans
- Training of investigational staff
- SAE-report review for accuracy and completeness
- Preparation of event reports
- CRF safety review
- Reconciliation of SAE data and study data base
For more information, please contact
Dr. Ulrike Schomaker
Project Manager
Project Manager
Phone: +49 (0)2234-20 37 37-16
Fax: +49 (0)2234-20 37 37-9
Studies
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
Julita Kelm-Woznaik
CRA Manager
CRA Manager
Phone: +49 (0)2234-20 37 37-23
Fax: +49 (0)2234-20 37 37-9
Send us an E-MailPhase II – IV / NIS
For more information, please contact
Project Management
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:
- Primary sponsor contact
- Project planning
- Preparations and start prerequisites
- Finalisation of study documents
- Project team Training
Development of study plans:
- Project
- Communication
- Monitoring
- Contingency
- Contract specific: Safety, Clinical Data Management, Statistical Analysis Plan
Financial management with regard to:
- Study budget
- Grant payments
- Payments to third parties
- Subject reimbursement
Running project to contract
- Communication
- Progress control
- Status reporting (vs. contract, timelines, milestones)
- Implementation of contingency plans and corrective measures
- Quality control
Project team support
Project completion and handover of the Trial Master File
Dr. Klaus Kühle
Project Manager
Project Manager
Phone: +49 (0)2234-20 37 37-15
Fax: +49 (0)2234-20 37 37-9
Quality Management
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:
- Trial-specific audits (e.g, on protocol, CRF, Trial Master File and on-site)
- System audits
- Vendor audits to verify conformity of conditions, practices and processes to all relevant regulatory requirements.
Sabine Kürpick
Lead QA Manager
Senior Project Coordinator
Lead QA Manager
Senior Project Coordinator
Phone: +49 (0)2234-20 37 37-19
Fax: +49 (0)2234-20 37 37-9
Regulatory Affairs
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.
Sabine Kürpick
Lead QA Manager
Lead Regulatory Manager
Lead QA Manager
Lead Regulatory Manager
Phone: +49 (0)2234-20 37 37-19
Fax: +49 (0)2234-20 37 37-9
Biometrics
gain valuable statistical insights and results
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.
Medical Writing
concentrate on the essentials
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.
Clinical Data Management
flexible EDC solutions; ePROs/eDiaries
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.
Monitoring
secures and objectifies your data
Clinical studies, 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.
Project Management
competent partners to all intents and purposes
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.
Quality Management
safeguarding quality
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.
Safety Surveillance
vigilance for confidence
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.
Regulatory Affairs
trust in acromion
Submitting applications for approval to conduct clinical studies to regulatory authorities can be a challenge. Despite the very advanced harmonization of the regulatory environment, there are still different local requirements to consider for certain clinical studies.
Studies
specialized scientific services
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).
