Study Feasibility and Consultancy Services
More than 80% of clinical trials fail to recruit at the predicted rates.
Phase I-III Clinical Trials
This is often due to inefficient clinical investigator selection, improper region preference, and poor understanding of ethical and local regulatory aspects of the selected sites and regions.
The result? Delays to the project timeline, and the increased costs incurred by those delays.
Clinical trial feasibility is therefore one of the most crucial steps in the management of any clinical programme.
TCR-Solutions will work with our sponsors to review and assess all aspects of the trial including:
- Entry criteria
- Visit schedule to ensure not overly burdensome to patients
- Use of specialist equipment and/or assessments and infrastructure requirements more generally
- Costs to both sponsor and patient
- Patient reimbursement
- Proposed investigator fees
- Investment of time and effort for patient
- Concomitant medication and comparator drugs – not all medications will be available or licenced globally which will impact the countries chosen to conduct the trial
- Cultural differences across regions
Identifying and setting up your ideal hospital partner sites
Hospital site selection is a vital component of your clinical trial’s success.
TCR-Solutions unique, in-depth, understanding of hospital people, processes and infrastructure means we are experts at selecting the very best investigative sites to achieve your project goals.
Our established relationships with with hundreds of tried and tested investigators across the UK, Europe, the USA, and Australia, means we are ideally placed to provide an integrated global feasibility process.
Once we have developed a shortlist of possible investigative sites, we assess their suitability, applying a rigorous and proven feasibility process.
Every site we recommend for your study will have been subject to a detailed qualifying interview by one of our senior management team.
Feasibility work often focuses on the number of patients at an investigative site who are eligible for the study.
While we recognise the importance of this metric, site facilities and infrastructure are also crucial success factors.
We will also take account of the bureaucratic procedures within the hospital, their likely effects on your study costs and on the time required to achieve study start-up.
TCR-Solutions have unique expertise in negotiation of contracts and budgets with hospital sites.
By leveraging our hands-on experience of working in the hospital system we ensure that contractual process moves forward rapidly and efficiently and we are ideally placed to ensure that the negotiation of the per-patient budget is conducted in a manner that is equitable for all parties.
Protocol Design
Creating the foundation for a safe and successful clinical trial.
Our established network of expert clinicians enables us to provide state-of-the-art medical and scientific input to your protocol design.
But in addition to scientific excellence, studies must also be practical and realistic.
TCR-Solutions personnel can leverage their many decades of experience to ensure that the protocol is designed with the nuances and challenges of real life in mind.
Overly restrictive inclusion/exclusion criteria can make recruitment virtually impossible and will lead to study failure. It is therefore important, prior to initiating any trial to assess every aspect of the planned study. Some protocol amendments cannot be avoided; however, the potential for amendments can be reduced with better planning and anticipation of the consequences of design choices.
A well designed protocol will motivate sites to recruit and retain patients, as well as moving your clinical development plans to the next phase.
Regulatory Affairs
Our Regulatory Affairs capabilities include advanced therapies, gene therapy and medical devices.
We will work closely with you to ensure that all documentation submitted is of the highest quality. Our network of local regulatory experts across Europe, USA and Australia ensure that these standards are maintained globally.
Project Management
A proactive and responsive service to maximise your study’s potential
Project Management is a key element of our clinical trial services.
Its success is based on effective communication with you and your team, site staff and trial participants.
We begin by working with you to collaboratively develop a set of comprehensive project plans, to predict and mitigate future challenges including an in-depth Risk Analysis.
Our detailed knowledge of hospital infrastructure, people and processes ensures that the plan is firmly grounded in the realities of conducting clinical studies in the real world. We have developed processes and ways of working that both involve and engage our contacts in the hospital sites. Our unique understanding of the environment means we work together with optimal efficiency.
Acting as a central point of contact for you and your colleagues, trial participants and site staff, we proactively and responsively maximise every opportunity to ensure your study meets its objectives on time and within budget.
Study Monitoring
Rely on our unrivalled experience for optimal study delivery
Our study monitoring service is conducted by an exceptionally experienced team of CRAs with a strong background in clinical research across both hospitals and academia.
This enables them to build strong and effective working relationships with study personnel based on mutual respect, and ensures that we achieve optimal results from our carefully selected investigative sites.
Our clinical study monitoring team has worked on a wide variety of clinical studies which means we are ideally placed to rapidly identify potential issues and deal with them accordingly. We are also accustomed to modifying our approach to monitoring and query resolution to encompass differing levels of Source Data Verification and risk-based monitoring strategies.
Biometrics,
Pharmacovigilance & Medical Monitoring
Included in our offering
Biometrics
Supported by leading Biometrics partners, we deliver the highest standards of quality to meet the needs of your trial strategy and timeframes.
We work closely with our sponsors to develop innovative data management applications across a wide range of therapeutic areas.
Our statistical services include modelling for pharmacokinetics, adaptive designs and much more.
Pharmacovigilance
Our high-quality services, provided by a range of pre-qualified providers, are customised to your requirements, and are fully scalable to meet the needs of your clinical trial.
Medical Monitoring
Our medical monitors, provided via Boyd Consultants, our preferred partner, deliver medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out.