Clinical trial services
Crossover has the skills set and experience to complement sponsors’ own in-house expertise. In particular, Crossover offers the following:
EudraCT application
We can apply for registration to the EudraCT database and obtain a EudraCT number for any studies to be conducted in the European Union.
European Union Legal Representative
Sponsors who are not located in the European Union may conduct studies within the EU. However, there is a legal need for them to have a formal representative, resident within the EU. With its experienced staff, Crossover is happy to provide this all important and critical support to its clients.
Protocol writing
Personnel at Crossover have extensive experience working on the development and execution of clinical trials protocols from Phase I to Phase IV and in all therapeutic areas. Protocols are the bedrock on which clinical trials are based and can be provided with the highest attention paid to quality and timeliness of delivery.
Ethics Committee (IRB) submissions
These applications, with some documentation needing to be translated to the local language(s), can easily be handled by Crossover’s multilingual and experienced research staff.
Investigator meetings
Whether the Investigator Meetings are local, national or larger multi-national ones, Crossover will be glad to assist sponsors in the design and running of these critical meetings.
Site ID and recruitment and patient recruitment strategies
Patient recruitment is one of the most critical factors in gauging the success of a clinical protocol and indeed a clinical development plan. Crossover's clinical and project management colleagues have many years of experience in executing strategies that ensure recruitment targets are met. These strategies embrace ensuring that the correct and realistic targets are set as well as providing rigorous feasibility assessments, the correct selection and mix of countries, inclusion and allowance for key opinion leaders, local approaches to patient targeting, referral strategies and robust real time project management.
Site set-up, monitoring and study close-out
Once healthcare institutions are identified, Crossover clinical research staff will immediately embark on setting up the individual investigative sites, liaising with hospital staff and Crossover CRU colleagues at selected institutions in the Crossover network. Once Ethics and Regulatory approval has been obtained, supplies received and all pre-study formalities completed, Crossover will monitor sites regularly and frequently to ensure that all trial objectives, both qualitative as well as quantitative, are met.
Auditing
Crossover audits hospitals in COCRIN annually. As part of a clinical study, Crossover can carry out a formal quality assurance audit. Systems audits and pre-inspection audits can be provided as a truly independent "stand alone" service.
Medical writing
The prompt and complete writing up of any scientific investigation and particularly a clinical trial is an essential component. The regulatory, ethical, legal and commercial importance of a well written and expeditiously submitted quality medical report is fully understood and well executed by Crossover medical personnel.
EudraCT application
We can apply for registration to the EudraCT database and obtain a EudraCT number for any studies to be conducted in the European Union.
European Union Legal Representative
Sponsors who are not located in the European Union may conduct studies within the EU. However, there is a legal need for them to have a formal representative, resident within the EU. With its experienced staff, Crossover is happy to provide this all important and critical support to its clients.
Protocol writing
Personnel at Crossover have extensive experience working on the development and execution of clinical trials protocols from Phase I to Phase IV and in all therapeutic areas. Protocols are the bedrock on which clinical trials are based and can be provided with the highest attention paid to quality and timeliness of delivery.
Ethics Committee (IRB) submissions
These applications, with some documentation needing to be translated to the local language(s), can easily be handled by Crossover’s multilingual and experienced research staff.
Investigator meetings
Whether the Investigator Meetings are local, national or larger multi-national ones, Crossover will be glad to assist sponsors in the design and running of these critical meetings.
Site ID and recruitment and patient recruitment strategies
Patient recruitment is one of the most critical factors in gauging the success of a clinical protocol and indeed a clinical development plan. Crossover's clinical and project management colleagues have many years of experience in executing strategies that ensure recruitment targets are met. These strategies embrace ensuring that the correct and realistic targets are set as well as providing rigorous feasibility assessments, the correct selection and mix of countries, inclusion and allowance for key opinion leaders, local approaches to patient targeting, referral strategies and robust real time project management.
Site set-up, monitoring and study close-out
Once healthcare institutions are identified, Crossover clinical research staff will immediately embark on setting up the individual investigative sites, liaising with hospital staff and Crossover CRU colleagues at selected institutions in the Crossover network. Once Ethics and Regulatory approval has been obtained, supplies received and all pre-study formalities completed, Crossover will monitor sites regularly and frequently to ensure that all trial objectives, both qualitative as well as quantitative, are met.
Auditing
Crossover audits hospitals in COCRIN annually. As part of a clinical study, Crossover can carry out a formal quality assurance audit. Systems audits and pre-inspection audits can be provided as a truly independent "stand alone" service.
Medical writing
The prompt and complete writing up of any scientific investigation and particularly a clinical trial is an essential component. The regulatory, ethical, legal and commercial importance of a well written and expeditiously submitted quality medical report is fully understood and well executed by Crossover medical personnel.