CROss Alliance® is the registered trade name for CROSS Research SA and CROSS Metrics SA, two private Swiss Contract Research Organizations (CROs) 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.
A twelve members team, with 3 Medical Doctors including a specialized clinical pharmacologists and several experienced study nurses are devoted to conduct the clinical part of the studies with an extreme professionalism. A continuous training, repeated for every single study to all the involved staff, and the strict respect of consolidated SOPs, provide a strong guarantee on the quality and reliability of the study results.
In addition, in the course of the years of activity, several 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.
More information about the 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, monitors, etc), in order to provide the Sponsor with only one contact point and trial responsible.
CROss Alliance®, taking advantage of a free-lance CRA network built in years of activity, provides monitoring services in Italy, Switzerland and in other EU countries, although, differently from the majority of CROs, monitoring does not represent our core business.
Through selected partners we can extend monitoring activities to US, South Africa and Eastern European countries and in case of monitoring subcontract, CROss Alliance® remains responsible for the CRA’ activities towards the Sponsor, reviewing every monitoring report in a due time before releasing it.
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 Metrics, the CROss Alliance company 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.