Services

Thanks to more than 20 years of activities in clinical pharmacology, and over 500 clinical studies successfully performed, CROss Alliance® team is able to provide an overall evaluation of clinical development plans in order to improve the risk / benefit ratio of each project.
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.

After discussing the project needs with the Sponsor, using the relevant support of the Biometry group, CROss Alliance team designs a tailored protocol synopsis in order to optimize benefits and budget available. The document agreed with the Client, is developed up to a complete ICH protocol by a dedicated and experienced Clinical Project Leader in collaboration with our Investigators, Biostatisticians and Medical Writing Unit.

Through the years, CROss Alliance® has acquired relevant clinical site selection skills and built its own clinical site database in several therapeutic areas.
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.

Based in the south of Switzerland, CROSS Research Phase I Unit, covers a wide range of clinical studies in healthy volunteers dealing with pharmacokinetic, pharmacodynamics, safety and local tolerability.

At present, more than 350 phase I studies including also trials in special populations (e.g.: elderly subjects, overweight, postmenopausal woman, etc..), have been performed in the Swiss unit.

A twelve-member team, with 3 Medical Doctors including a specialized clinical pharmacologist and several experienced study nurses are devoted to conduct the clinical part of the studies with 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 of the quality and reliability of the study results.

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.

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: ACTide® Clinical Solution (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.

Activities are performed by our dedicated Medical Writing Unit, in full compliance with ICH guidelines and CROss Alliance SOPs. Our team has an extensive and documented experience not only in medical writing but also in regulatory activities and requirements, including all aspects related to clinical trials design and management.

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):

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.