{"id":825,"date":"2018-07-05T15:19:59","date_gmt":"2018-07-05T13:19:59","guid":{"rendered":"https:\/\/www.croalliance.com\/services\/"},"modified":"2026-01-07T16:35:04","modified_gmt":"2026-01-07T15:35:04","slug":"services","status":"publish","type":"page","link":"https:\/\/www.croalliance.com\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"

[vc_row][vc_column][vc_single_image image=”1067″ img_size=”full” alignment=”center” el_class=”fullwidth”][vc_empty_space height=”10px”][vc_column_text]CROss Alliance\u00ae<\/sup><\/span> is the registered trade name for CROSS Research SA<\/strong>, a private Swiss Contract Research Organization (CRO) active in the field of clinical development of drugs, medical devices and nutraceuticals products<\/strong>.<\/p>\n

CROss Alliance\u00ae<\/sup><\/span> services can be highly tailored in order to range over the needs of biotech organizations, small-medium size pharmaceutical companies \u00a0and also to accomplish the requests of larger multinational pharma industries.<\/p>\n

Clinical development and trials that can be handled include: New Molecular Entities (NME’s), New Indications, New Technologies or Delivery System, New Formulations, Biosimilar, Generic Drugs & devices.[\/vc_column_text][vc_empty_space height=”20px”][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_accordion style=”flat” shape=”square” color=”white” active_section=”0″ no_fill=”true” collapsible_all=”true”][vc_tta_section title=”Overall project development & consultancy” tab_id=”overall-project-development-and-consultancy”][vc_column_text]<\/p>\n

Thanks to more than 20 years<\/span> of activities in clinical pharmacology, and over 500<\/span> clinical studies successfully performed, CROss Alliance<\/span>\u00ae<\/span> team is able to provide an overall evaluation<\/span> of clinical development plans<\/span> in order to improve the risk \/ benefit ratio of each project.
\nIn addition, senior in-house staff<\/span> 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.
\nOur deep knowledge of phase I studies<\/span> 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.
\nFor phase II \/ III studies<\/span>, in several therapeutics areas, selected clinical sites with high medical specialization and compliance to GCPs are available.
\nThis relevant portfolio<\/span> built through years of activity, facilitates a preliminary, but realistic, overview of the resources and budget needed to reach the project objectives.<\/div>\n

[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Study design & study protocol” tab_id=”study-design-protocol”][vc_column_text]<\/p>\n

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

[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Clinical sites identification” tab_id=”clinical-sites-identification”][vc_column_text]<\/p>\n

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Through the years, CROss Alliance\u00ae<\/sup><\/span> has acquired relevant clinical site selection skills and built its own clinical site database<\/span> in some therapeutic areas.
\nOur long experience in the clinical trial performance in several European Countries (among them Austria, Hungary, Italy, Sweden) plus Switzerland,\u00a0allow a smooth access to the clinical site networks<\/span> also through the cooperation with local monitoring organizations.
\nIdentified sites, according to client needs, are qualified or audited before being included into a collaboration proposal. Continuous assessment regarding sites reliability and performance are strictly monitored in order to maintain or improve quality.<\/p>\n<\/div>\n

[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Phase I studies in healthy volunteers” tab_id=”phase-i-studies-in-healthy-volunteers”][vc_column_text]<\/p>\n

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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.<\/p>\n<\/div>\n

Based in the south of Switzerland, CROSS Research Phase I Unit<\/span>, covers a wide range of clinical studies in healthy volunteers dealing with pharmacokinetic, pharmacodynamics, safety and local tolerability.<\/div>\n
At present, more than 350 phase I studies<\/span> including also trials in special populations (e.g.: elderly subjects, overweight, postmenopausal woman, etc..), have been performed in the Swiss unit.<\/div>\n
A twelve-member team, with 3 Medical Doctors<\/span> including a specialized clinical pharmacologist and several experienced<\/span> study nurses are devoted to conduct the clinical part of the studies with extreme professionalism.<\/div>\n
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.<\/div>\n
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In addition, in the course of the years of activity, several clinical models<\/span> 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<\/span> for their new drugs or formulations.<\/p>\n<\/div>\n

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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.<\/p>\n<\/div>\n

More information about CROSS Research Phase I Unit are available here<\/a>.<\/strong><\/div>\n

[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Phase I \/ II \/ III international trials coordination” tab_id=”phase-i-ii-iii-international-trials-coordination”][vc_column_text]<\/p>\n

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CROss Alliance\u00ae<\/span> experienced Clinical Project Leaders<\/span> 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<\/span> and trial responsible. Differently from many of our competitors, CROss Alliance staff is mainly 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 colleagues and also with the other company Units located in the same HQ office in Switzerland. Additionally, \u00a0it guarantees to our Sponsors a very quick reaction time in case of need or issues that may raise during the conduct of a clinical trial.<\/p>\n

Finally, thanks to the implementation of the European Clinical Trials Information System (CTIS) any EU study can be submitted for regulatory approval in the target Countries, directly by the experienced CROSS CTA Team based at CROss Alliance HQ.<\/p>\n

CROss Alliance\u00ae<\/span>, taking advantage of a network of freelance CRAs and local CROs <\/span>built in years of activity, provides monitoring services in Italy, Switzerland and in other EU countries. However, 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, and for any subcontracted activity, CROss Alliance\u00ae<\/span> remains responsible towards the Sponsor, overseeing every step and providing advice for any trial-related decision.<\/p>\n

Extended monitor’s study training is always set before trial starts, while continuous GCPs refresh or update is provided to monitors by CROss Alliance Quality Assurance Unit or by relevant courses.<\/p>\n

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.<\/p>\n<\/div>\n

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