Java's Clinical Trial Services
Project Management
Our team of Project Managers have experience in both the pharmaceutical and CRO industries. They understand the complexities of running a clinical research study and all that is necessary for a successful conclusion.
For all our clinical studies, a dedicated Project Manager is assigned to assume the responsibility of overall project coordination and puts in place a clinical project management plan to ensure the success of the project. This Project Manager works with the sponsor to determine the project scope, and acts as the sole point of contact between the sponsor and all third party vendors. The Project Manager contacts the sponsor project team proactively and frequently to ensure they are kept fully briefed on study progress and informed of any significant study or site issues.
Project tracking ensures study milestones are met within the required timeframes, with the Project Manager responsible for putting in place and implementing contingency plans when required. The project management team works closely with the CRAs assigned to the project to ensure that all study and site issues are quickly identified, and we call on our extensive experience in clinical research to ensure these are rapidly and appropriately resolved.
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Clinical Monitoring
We only assign skilled and well-trained Clinical Research Associates (CRAs) to our clinical trials to ensure that the highest standards of quality and professionalism are achieved, including effective interaction with site personnel.
We advocate frequent, proactive site monitoring at the initial stage of patient recruitment into a clinical research study in order to:
- motivate site personnel and focus investigators on patient recruitment
- help identify and resolve early any issues the sites may encounter with the clinical trial protocol, good clinical practice, or overall conduct of the study
- ensure patient recruitment targets are met in a timely manner
- ensure that sites’ data quality and accuracy is of the highest standard
Thereafter, a CRA will conduct site monitoring at regular intervals to ensure visits are being conducted within the correct time period and in accordance with the protocol, that the clinical data captured is accurate and of highest quality, and that the study is being conducted in compliance with ICH/GCP guidelines and standards.
In addition to the clinical trial monitoring visits, the CRAs maintain contact with each centre on a regular basis in order to maintain site motivation, optimise recruitment and patient retention, and address any issues or queries that may be identified.
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Competent Authority Submissions and Ethics Committee Applications
Our regulatory team have considerable experience in dealing with the procedures and documentation required for Competent Authority and Ethics Committee submissions throughout Europe. This local expertise and familiarity with the submission process can help ensure that submitted Clinical Trial Applications (CTAs) are complete and accurate, as required by the EU Clinical Trials Directive (EU Directive 2001/20/EC) and any other applicable regulatory requirements such as FDA regulations, and can help prevent unnecessary delays occurring as a result of incomplete or incorrect submissions.
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Protocol Writing
The clinical trial protocol is a vital reference document for use by all participating study personnel. At Java, we understand how important it is that clinical study protocols describe all relevant information required to conduct the study uniformly and to the highest standards, and that protocols are written with clarity and specificity.
The team at Java has considerable experience in developing and writing clinical research protocols in accordance with ICH/GCP guidelines and other applicable regulatory requirements. Every protocol is developed in collaboration with the Sponsor in order to ensure that the Sponsor requirements and objectives are being addressed, as well as the needs of protocol end-users, such as clinical investigators, site nurses and other staff.
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GCP SOP Writing
A Standard Operating Procedure (SOP) is a set of detailed, written instructions that specifically describe how to complete research-related activities. Well-written procedures, defining how each task should be performed, greatly facilitate compliance with the protocols, laws and regulations that govern the conduct of clinical research. Use of SOPs forms a central part of good clinical practice and may expedite clinical trial audit procedures. In addition, they improve efficiency, communication and training of staff.
Java has the capability of writing Standard Operating Procedures for investigative sites to enable them to comply with GCP. We also offer an SOP management service, where we review your existing SOPs to determine their compliance with current regulations and guidelines, recommending additions and revisions if necessary.
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ICH-GCP Training
Ongoing staff training is essential to maintain the optimum performance, knowledge and skills of all personnel participating in clinical research. Java offers a wide range of clinical research training courses, tailored to meet clients’ specific needs, including:
- Overview of Clinical Research
- Clinical Research Regulatory Affairs
- Clinical Trial Management
- Personal Development Skills
- Management Training Courses
If you have a group of people within your organisation requiring training, Java can deliver our clinical research courses through in-house training workshops. This provides cost-effective employee training and development for both commercial and non-commercial organisations.
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ICH-GCP Audits
We provide consultancy and expert audit services to assist and enable compliance with GCP, and all other applicable regulatory requirements. Services offered cover all aspects of Good Clinical Practice and are customised to meet each individual client’s needs and can include:
- Investigator Site Audits
- Trial Master File Audits
- Clinical Research Centres Facility Audits
- Vendor audits of CROs and other subcontractors
- Standard Operating Procedures Administration Systems Audit
Following each audit, the audit findings are detailed in comprehensive and confidential audit reports and certificates issued to the client and auditee.