What We Do
It is difficult to overestimate the importance of local knowledge of regulatory requirements while performing study regulatory support. Different countries have different regulatory pathways and timelines – some countries require both National and Local Ethics Committees / Institutional Review Board (IRB) approvals, some require Local Ethics / IRB approvals before national submission; some require fully-executed site agreements before submission to the Competent Authorities, and some require such agreements before actual approval is granted. There are different requirements on import and export licenses, local insurance, principal investigators’ certification, and much more. The ins and outs of obtaining regulatory approval can throw up a myriad of issues, but with 30 years of experience in the field, we are adept at working in complicated regions. We rely exclusively on local regulatory specialists who know all the bottlenecks of local regulations and prevent delays in obtaining all necessary approvals.
The regulatory specialist will assess whether the study is suitable for the local jurisdiction at the feasibility stage, then provide a list of required documents, a process workflow, and an official timeframe supported by local experience.
The goal of project management is to ensure smooth project performance with no disruptions. We realize that proper planning is the cornerstone of every project, and we put special emphasis to development of and adherence to project plans, i.e. study-wide Project Plan, Communication Plan, Risk Management Plan, etc.
Confidence believes that an experienced and dedicated Project Manager is instrumental to the execution of a successful clinical research program. Our Project Manager takes direct responsibility for all aspects of the project, as well as for the project team. Project Manager also serves as the sponsor’s primary contact for the duration of the project. By creating these direct lines of responsibility from the Project Manager to the Sponsor, to the study team, to other departments within Confidence, and to vendors, Confidence ensures accountability, efficiency, and responsiveness.
Risk management is a large part of Project Management. We know that you can’t predict the future, but it’s paramount to evaluate all possible issues – ranked by probability and impact – in order to develop a comprehensive mitigation strategy. Confidence will develop comprehensive risk management plan, which will identify different kind of risks (operational , regulatory, logistics, enrollment, etc.) and propose possible contingency plans.
Rigorous risk management reduces costs of operations and overhead expenses. Transparency of all operations, communications, and operational risk sharing is a key to honest and open partnerships between Sponsor Confidence , bringing about successful project performance.
Negotiating fair grants to Sites and Principal Investigators can be tricky. Sponsors, who are paying the grants, may look at similar studies and workloads and draw conclusions about costs; likewise, Principal Investigators, who do the work, will have their own views on what constitutes fair compensation; in addition, regulatory considerations may also apply.
Paying grants in a timely manner still presents logistical issues, especially if a third party is processing payments and the trial is taking place in a country where payments can only be done locally. We bring experience and integrity to the process by helping establish mutually advantageous grant terms and streamlining the payment process, both of which will increase the Sites’ motivation and shorten trial times.
We believe that successful site selection requires competent, careful planning with solid demographic and infrastructure data, and the use of accurate past performance metrics.
Confidence’s vast experience in global clinical research helped us to build wide network of investigators who are willing to participate in our studies. In addition, Confidence uses its home-built proprietary online application MedMap, a database of over 10 million clinical investigators and biomedical research experts all over the world. It allows us to reach out to thousands of investigators and clinical sites in seconds, and is instrumental during the feasibility process and when Confidence needs to identify opinion leaders in any therapeutic area.
Conducting studies in more than one country and in more than one language is now par for the course, but translation is a multifaceted affair.
Equality and diversity in clinical studies is vital: it doesn’t make sense for a patient who presents perfectly for a trial to be turned away because they don’t speak English. But India has over thirteen languages, each with more than ten million native speakers; Switzerland has four official languages; Latvia speaks seven.
Patient questionnaires and administration leaflets don’t just need to be translated, though; they need to be transcreated to take account of the nuances of local culture as well as distinct jurisdictional requirements. Furthermore, while assessing the patient – collecting outcome metrics and asking questions about quality of life – we need to be conscious of local norms. Being culturally sensitive is all part of the translation process.
Confidence provides translation and cultural adaptation and validation services using comprehensive procedures with built-in quality checks.
CONFIDENCE Clinical Data Management and Statistics adhere to all the applicable standards, laws and guidelines of quality and truthfulness in scientific research. Our Data Management and Statistics specialists are involved in project planning from the start, work with other functional groups, and are part of all relevant study decisions. We provide all Data Management services, from development of the Data Management Plan and development of the eCRF, to the building and validation of the EDC system, to the Database Lock. Our programmers and Data Managements have experience working with different EDC systems, and will be happy to either propose our solution, or work with the system of your choice.
Our Biostatisticians have vast experience in clinical trials – from developing the protocol’s Statistics section to participating in meetings with the FDA/other Competent Authorities, to the development of the Statistical Programming Plan and Statistical analysis, to writing the Clinical Study Reports.
It’s critical to have a well-formulated Study Protocol which outlines the program’s scientific goals and has a deep understanding of the therapeutic field, justified sample size, meaningful inclusion/exclusion criteria, and clearly stated procedure requirements, while meeting the requirements of a highly regulated field. It’s equally critical to develop Informed Consent Forms (ICF) which meet the requirements of regulatory bodies in different countries, be it for clinical research in conventional settings, or pediatric research, or research in acute patients where somebody else needs to give consent for the patient to participate in the study. Confidence Medical Writers have experience in development of the Study Protocols in different therapeutic areas and in different study phases. In cooperation with Regulatory specialists and experienced trialists, our Medical Writers develop ICFs which meet the requirements of multiple Regulatory bodies and Ethics committees.
We can help entrepreneurs at every stage. With over 30 years of hands-on experience in the field, when it comes to giving clear, impartial and constructive feedback, we know what we’re doing – and as your company grows, we know what you should be doing too.
Responding to change while your company is growing is complex – like learning to juggle on the deck of a yacht in a storm. But it’s vital, too, because managing a successful company is about managing change*.
First time entrepreneurs need to learn how to create scalable management models – no mean feat when you’ve spent the first few years wearing every hat from the CEO to the receptionist. But we know that from business process re-engineering to employee engagement and leadership, as transformation impacts on the comfortable status quo, it’s all about planning ahead. Perhaps never more so then when picking the right moment to exit, so that you maximise return on investment, while ensuring that the company you created has a sustainable growth path after you’re gone.
Every entrepreneur could do with sensible advice, clearly and honestly stated – let us share our knowledge with you. And of course, discretion, confidentiality and honesty come as standard.
* A farmer must transport a wolf, a goat and a cabbage across the river – but the boat only holds him and one other, and the wolf cannot be left with the goat, nor the goat with the cabbage — The old puzzle, 9th Century
Meetings are a great way of injecting energy and enthusiasm into a clinical trial, but half a day frittered away in an anonymous hotel conference room is demotivating and unproductive – and, crucially, it’s also a waste of budget. But meetings needn’t be a chore.
We understand that bringing large numbers of busy physicians together is an undertaking, which is why, from that start, we make sure planning is precise, schedules straightforward, and goals clear. We don’t waste time on basics that people can brief themselves on at home; instead, we ensure that conferences are used to share opinions, generate ideas, and build trust and relationships between attendees.
We learned that people enjoy sessions where they feel that their contribution is valued, and in the end this impacts on the study. Fundamentally, successful interim meetings mean successful studies.
Comprehensive and effective auditing makes for more efficient and more dynamic studies: from helping to explain past mistakes and improve current trials to proposing better approaches to future studies, they’re about making trialists better at their jobs.
Even the best standard operating procedures don’t guarantee an error-free trial. Good results are a combination of well-honed operational management and precise metrics and business acumen. A clinical trial audit should evaluate a complex set of systems in order to reveal where they fall short and where they could be improved. Audits help to streamline current studies while flagging up potential issues and possible incidents in future trials.
Confidence Auditors are seasoned Quality Assurance specialists and Certified Quality Auditors with the expert knowledge of CPP, GLP and GMP compliance regulations and industry practices.
Confidence provides a full range of Site Monitoring – Site Selection, Site Initiation, Routine Monitoring, and Site Close-Out Visits. The visits can be conducted on-site or remotely under Confidence SOPs which adhere to all international and local requirements. All visits are conducted according to the Sponsor-approved Clinical Monitoring Plan. Visits are scheduled and reported within the Confidence Clinical Trial Management System (CTMS), accessible by the Sponsor. The Issues Log, Action Items, and Protocol Deviation Log are also tracked in the CTMS, providing transparency to the Sponsor at any given time.
Continuity is key in trials, and we understand the importance of having Clinical Research Associates (CRAs) that see a study through from start to finish. Industry-wide, CRA turnover is the highest of all staff at CROs. Staff turnover at Confidence is minimal to none, and we work only with experienced CRAs with whom we have outstanding, transparent relationships. And it is these trusted contacts, coupled with our top-tier selection of sites and Principal Investigators, that keep your trial productive.