As experts in the more challenging aspects of setting up a trial, as well as the standard processes, we will support you every step of the way, allowing you to concentrate on what you do best while we work on our specialisms to create the strongest possible plan for your trial to flourish.
The following represents just some of the services we offer, but please get in touch to discuss your requirements and we will gladly help.
At Ixia Clinical we are highly experienced at dealing with regulatory boards and ethics committees, having forged strong and lasting relationships with several institutional bodies. We are experts in skilfully navigating the requirements for the preparation and submission of trials for ethical and regulatory consideration in the shortest possible timeframes.
Our team can either provide support to your regulatory operations or take charge and manage the entire approvals process. This can be done at all phases of the product life-cycle. We are flexible to meet the needs of your project and can advise on the most effective solutions and strategies to achieve your project objectives.
The success or failure of a study can hinge on the quality of the protocol. At Ixia, we are practised protocol developers, be it building on minimal information in a basic synopsis or editing and streamlining a first draft document.
Our team use their detailed knowledge of working protocols to create a document that is infallible yet easy to use as a tool to aid the study process. We believe that a protocol should be an active and useable part of any trial and, as such, endeavour to keep our protocols as simple as they can be, all the while keeping the focus of the study at the heart of the developed document.
Ensuring the viability of studies is critical during the funding phase and our team are experts at helping to identify whether a trial can be delivered effectively. Our excellent working relationships with some of the most influential and high profile consultants, not just in the UK but worldwide, enables us to deliver comprehensive feasibility studies for projects across multi disciplines and requirements.
Delays can be costly in many ways and our team plan carefully to ensure accurately reported feasibility and timely delivery of
Our business is founded on providing a highly organised approach to clinical study project management. Our approach is defined by our unique processes which are highly structured and documented in straightforward, user-friendly standard operating procedures which enable us to deliver a comprehensive and successful solution on every project.
We regularly monitor and report on progress throughout the project life-cycle ensuring each project is kept within agreed timelines and our project costs adhere to agreed project budgets at all times.
For the successful completion of trials, it is critical that the investigator sites chosen are able to manage the trial process on time and within budget to ensure the high quality production of data.
We work with teams across the UK and beyond to help select sites and investigators that are highly competent and deliver excellent levels of data for every trial we manage.
The set up process and ongoing continued monitoring of clinical trials and medical device studies is the bedrock of our business. Covering the process from study conception right through to project completion, our team are highly skilled at all facets of the clinical trials and medical device studies process.
From evaluating the suitability of investigators and their sites (see section 5), through site set up and patient recruitment, to the clinical monitoring process and finally the completion and closure of the trial on site. Our team are highly experienced at managing the clinical trials and medical device study process at all phases of the development life-cycle. If required, we can have as much input as desired on aspects such as the monitoring plan and report structure. We have much experience within monitoring and are extremely well-placed to advise on the best practise, tailored perfectly to your individual needs.
Ensuring successful patient recruitment is key to the success of any trial and our record of achieving agreed patient recruitment targets is excellent.
With careful project planning at the outset, followed by a comprehensive ongoing problem identification and resolution process, we are able to resolve recruitment challenges quickly and effectively resulting in a successful rate of patient recruitment and retention.
For more information about our clinical study and medical device study procedures and how we can help you achieve your study objectives, please contact our team.
We will work primarily from a protocol (be it one that we have designed ourselves or a pre-existing document) to produce robust CRF content and collect the essential trial data. This can be done for paper CRFs, or we can deliver complete eCRF solutions through one of our trusted partners.
Too often, clinical teams are presented with messily designed CRFs that do not get to the heart of the primary and secondary endpoints of the study at hand. Ixia’s development and design team prioritise streamlined and neat forms, forgoing extraneous information and ensuring clinical staff at both site and CRO the easiest and most convenient means of data collection, query raising and resolution, discrepancy management, database locking and monitoring possible.
Whether you need white papers, publication summaries, regulatory documents, manuscripts or other medical and technical writing, the team at Ixia can deliver documents across the pharmaceutical, biotechnology and medical device fields. Right from initial discussions through to review and delivery of a final document, we will work with you to ensure a focused and cohesive report or publication.
We relish challenges and would love to hear from you regarding your medical and technical writing needs.
Clear and easy-to-use SOPs should form the foundation of any successful company, as they ensure consistent practice across every conceivable facet of the business. Having seen and worked from many SOPs in the past, we have a detailed understanding of what works and what doesn’t. Ironclad procedural documents don’t just ensure optimal performance from your team, they are an excellent means of protecting yourself against the identification of deficiencies should an audit be performed.
If you are just starting out, we are happy to write your SOPs from scratch. If you are a more established business, we can review your pre-existing SOPs and test them to identify points at which they could potentially be improved.
Please contact us to discuss your specific project requirements.