CROss Alliance® is the registered trade name for CROSS Research SA, a private Swiss Contract Research Organization (CRO) active in the field of clinical development of drugs, medical devices and nutraceuticals products.
CROss Alliance® services can be highly tailored in order to range over the needs of biotech organizations, small-medium size pharmaceutical companies and also to accomplish the requests of larger multinational pharma industries.
Clinical development and trials that can be handled include: New Molecular Entities (NME’s), New Indications, New Technologies or Delivery System, New Formulations, Biosimilars & Generic Drugs.
In addition, senior in-house staff is available to support our clients in the preparation of Scientific Advise meeting with relevant Competent Authorities and, when requested, can take part in the meeting together with the client acting as a professional consultant.
Our deep knowledge of phase I studies allows us to timely provide comprehensive quotations of studies performed either in our Phase I Unit in Switzerland or in the Phase I Unit of Clinical Pharmacology Department of Vienna Medical University.
For phase II / III studies, in several therapeutics areas, selected clinical sites with high medical specialization and compliance to GCPs are available.
This relevant portfolio built through years of activity, facilitates a preliminary, but realistic, overview of the resources and budget needed to reach the project objectives.
Our long experience in the clinical trial performance in Austria and the leadership that Austria maintains among Eastern European countries, allow a smooth access to the Eastern clinical site networks also among cooperation with local monitoring organizations.
Identified sites are visited or audited before including them into a collaboration proposal. Permanent checks regarding sites reliability and performance are kept in order to maintain and improve quality.
The design and conduction of phase I clinical studies was, from the beginning, the core business of CROSS Research; nowadays, after more than 20 years from the company foundation, phase I studies still remain a point of strength, know-how and expertise build up in over two decades.
In addition, in the course of the years of activity, several clinical models have been developed or tested in our facility; now all this experience can be deployed for our Clients in order to obtain an anticipated proof of concept for their new drugs or formulations.
Finally, for the limited panel of studies that need to be performed in a hospital based unit (i.e. NCEs), a long term collaboration is established with the Clinical Pharmacology group operating at the AKH in Wien where CROSS can provide an all-inclusive service, the strict respect of planned time lines and transparent costs.
More information about CROSS Research Phase I Unit are available here.
CROss Alliance® experienced Clinical Project Leaders manage phase I, II and III clinical trials all over Europe, coordinating in-house and external activities as well as different study players (Competent Authorities, Ethical Committee, Investigators, laboratories, local CROs, monitors, etc..), in order to provide the Sponsor with only one contact point and trial responsible. Differently from many of our competitors, CROss Alliance staff is office based, this set up allows our team members to develop a continuous growth in terms of experience and problem solving due to the mutual interaction within the Clinical Project Unit and also with the other company Units located in the same HQ office in Switzerland. Additionally, it guarantees to our Sponsor a very quick reaction time in case of need or issues that may raise during the conduction of a clinical trial.
CROss Alliance®, taking advantage of a free-lance CRAs and local CROs network built in years of activity, provides monitoring services in Italy, Switzerland and in other EU countries, although, differently from the majority of clinical CROs, monitoring does not represent our core business. Through selected partners we can extend our activities to several Eastern European countries, Russia and South Africa and for any activity subcontracted, CROss Alliance® remains responsible towards the Sponsor, reviewing every step and providing advice for any relevant decision concerning the trial.
Specific monitor’s study training is always set before trial starts. Continuous GCP training update is provided to monitors by CROss Alliance Quality Assurance Unit or by relevant courses. Clinical studies in our two preferred sites, CROSS Research Phase I Unit (Arzo, CH) and Vienna Medical University Hospital (Wien, AT), are closely monitored by CRAs very familiar with the clinical center and its standard procedures. 100% Source Data Verification versus CRFs can be provided as well as a risk based monitoring approach while on time delivery of monitoring reports to the Sponsor is considered of high priority.
- Up-to-date technologies & features: Oracle Clinical Database (fully validated & CFR 21 part 11 compliant), SAS®, Phoenix WinNonLin® (fully validated), MedDRA & WHO-DD databases, CDISC & ICH standards.
- Wide experience in overall trial activities from study protocol and CRF design, through sample size calculation and production of statistical report, Tables, Figures and Listings (TFLs) customized to specific Sponsors’ needs.
- The standardized procedures in place guarantee timely delivery of high quality data and the fulfillment of regulatory requirements.
CROSS Research’ Biometry Unit is completely devoted to satisfy your biometry needs. To learn more about our capabilities, have a look here.
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They are active members of the European Medical Writers Association (EMWA) and are enrolled in the EMWA Professional Development Programme at both fundamental and advanced level.
CROss Alliance Medical Writing Unit designs and maintains templates for CSP and CSR, assuring inside company standardisation and quality of the documents. They provide project management of writing-only projects.
Activities are carried out in close collaboration with Project Leaders, Investigator(s), Biometrics and PK/PD unit(s) and the Sponsor.
Summary of medical writing activities:
- Clinical Study Protocols, (CSP) preparation or revision, in compliance with ICH GCP Topic E6(R1).
- Clinical Study Reports, (CSR) preparation or revision, in accordance with ICH E3 Note for Guidance on Structure and Content of Clinical Study Reports and Final integrated CSR, including all appendices. CSR are released as eCTD-ready or as fully eCTD-compliant documents, upon Sponsor’s request, in accordance with the ICH M2 Expert Group eCTD Specification Document in both electronic and paper copy.
- Investigator’s brochures, (IB) preparation or revision, ICH E6(R1)-compliant.
- Investigational Medicinal Products Dossier, (IMPD) are usually revised upon specific Sponsor’s request; occasionally IMPD are entirely prepared, (CMC part is provided by Sponsor).
- Other regulatory documents, or Medical Affairs departments support, as required, e.g.: Abstracts for conferences, Expert reports, replies to Regulatory Authorities in relation to Clinical Trial Applications (clinical part only), Paediatric Investigational Plan, (PIP) preparation or revision, detailed Study Synopsis for request Competent Authorities advice.
CROss Alliance Quality Assurance Unit, enforces the highest quality standards to ensure that all the CRO activities are performed and the data are generated, recorded, and reported in compliance with ICH-GCP and the applicable regulatory requirement(s):
Quality is ensured through:
- Documented, SOP based, work-flow;
- Systematic, documented and effective controls of all study steps (from protocol to final report and archiving);
- Systematic, documented subcontractors audits (e.g. analytical and clinical labs) to ensure reliability and compliance to the highest quality standards;
- Continuous and documented training to ensure that the staff is always qualified and updated with the latest regulatory requirements;
- Tight connection with Quality Associations (e.g. RQA formerly Barqa & Giqar);
As additional service, we provide:
- Audits to facilities, trials and registration dossiers to assess compliance with Clients requirements and/or national or international quality standards;
- GCP training to Investigator or key study staff member (being CROSS Research officially recognised as GCP Training Provider at Investigator level by Swissethics).
CROss Alliance® experienced staff prepares and presents the Clinical Trial Application (CTA) package to gain regulatory approval for clinical studies from the relevant Ethics Committee and Central Agencies in Switzerland and all Europe.
After study completion, our group has in-house skills and background experience to support our Sponsors in answering all the questions related to the performed clinical part that may arise from Regulatory Authorities throughout the marketing authorization process.