Clinical research is a highly dynamic environment where no two projects are ever the same. In response, we continually develop our full-service capabilities to always meet the specific requirements of your study.
Scientific research in humans is intrinsically complex and involves navigating through the changing and dynamic regulatory environments, especially when the research is done across multiple countries, with different legislative framework.
Legislations are set to protect patient’s safety and the scientific value of the research data. Therefore, results require certain- critical administrative steps, that enable national competent authorities and Ethics Committees / IRBs sufficient information, to decide whether the proposed research is acceptable. However, laws and guidelines provide framework and not instruction on how the trials are approved or conducted.
At the intersection of international standards for human research (Declaration of Helsinki, Good Clinical Practice Guidelines, and similar), national legislative framework (regulations, directives, laws, and bylaws), and local guidelines (national or institutional), stands local regulatory expertise and knowhow, which helps navigating through a highly complex matrix of administrative tasks. These tasks need to be completed to ensure regulatory green light is obtained, so that sites may start with successful enrolment.
By utilizing our experienced, highly educated, and knowledgeable local experts, we make sure our local country teams deliver in accordance with planed timelines. Our teams are known to be resilient in unpredicted situations, which might occur during start-up and clinical trial regulatory maintenance phase.
These local experts are subject matter experts in essential documents, local insurance requirements, budgets and site agreements, local regulatory and ethics submissions, informed consent forms (ICFs) and consenting process, and understand the nuances presented by each location’s specific demands and processes. Optimapharm is also proud to have a very low turnover rate, which has been compared to industry standard.
In addition, our country and regional leads have significant clinical trial experience that will prevent any local specifics and potential delays. These delays can be detected and properly communicated to functional lead roles (Clinical Project Managers and Regulatory Managers), and with their involvement of reaching out to KOLs serves as a safeguard for minimization of potential start up delays.
Our expertise is also demonstrated by our `successful regulatory and ethics submissions of clinical trials across a wide range of clinical programs and settings including medical devices, drugs and biologics, vaccines, ATMPs and other healthcare products.
Review of existing regulatory documentation
Regulatory advice – developing a robust regulatory strategy
Managing Clinical Trial Applications towards Competent Authorities and IRBs/IECs
Managing Clinical Trial Registers
Meetings and communications with Competent Authorities and IRBs/IECs
Advice for the development of IMP label and local adaptations of essential study documents
Clinical trial regulatory updates to Competent Authorities and IRBs/IECs
Management of local and international compliance submissions
Adaptation of trial documentation to local regulations (e.g. Informed Consent Form, Application Forms, management of import and export processes).
Our monitors are a vital cog in the machinery of your clinical trial. They provide invaluable support to principal investigators and their study teams, help to assure quality and safety for both sites and patients and work to keep your trial running smoothly.
Our monitors all have university degrees, predominantly in medical and life sciences, and, on average, they have more than five years of experience in the role. Pragmatic and diligent, you can depend upon them to handle any issues quickly and professionally – keeping the day-to-day progress of your trial on track.
We allocate our monitorsand CTA staff to each study based on their previous experience in similar studies and their expertise in a particular therapeutic area or indication.
We always make sure there are appropriate internal supervision procedures in place and that a sponsor has a clear point of contact should any feedback need to be escalated. Continuous monitoring for the duration of a trial is guaranteed with trained backup staff allocated to cover any unexpected situations or unforeseen absences.
Maintaining continuity of project teams is important for sponsors and we are proud of our extremely low rates of staff turnover which, for operations staff in 2020, was less than 6%.
Our trials are assiduously patient-centric – an approach where safety always comes first. Our aim is to facilitate recruitment and reduce the number of withdrawals, while making sure your project requirements are fulfilled.
Feasibility assessment, site qualification visits
Site selection, Initiation, ongoing Monitoring and Close out visits
Continuous liaison, training, support and motivation for investigators and other site personnel
Verification of source data as well as protocol, regulatory and ICH GCP compliance
Critical review procedures:
IMP, other drugs and supplies logistical processes;
regulatory binders and site files;
informed consents and consent process;
AEs and SAEs management and ensuring subject safety;
lab sample and supplies handling and reporting procedures;
data and data collection methods
Risk assessment, evaluation of enrolment goals and troubleshooting site performance
Preparation of corrective and preventative (CAPA) plans and proactive follow-up to issue resolution
Provision of all monitoring and other on-site/remote visit reports
Managing clinical trials is a highly regulated and complex process involving multiple stakeholders. Missed deadlines cost your organisation in terms of revenue and reputation. High quality supervision is one of the most important factors in delivering a successful, on-time and on-budget outcome.
Our clinical projects managers sit at the heart of each project, providing the organisational and communication hub around which the project sponsor, the trial sites, the project team and our oversight function revolve. They all have deep experience managing cross-functional teams to make sure that key performance indicators and project milestones are met.
We allocate our clinical project managers carefully, taking into account their expertise and experience of relevant therapeutic areas and indications and the trial phase.
Recognising the importance of the role, we have established a specific department to closely supervise all clinical project management activities and project delivery. Continuity of project management over the course of a trial can be vital to a successful outcome, so we are proud to state that in 2020 our project management staff turnover was 0%.
Our Clinical Trial Management System (CTMS) provides an effective framework to support project management activity delivering easy access to centralised data, accelerating clinical trials and minimising potential delays.
Project planning, scope of work, study tracking and reporting
Creation of project plans
Risk management and mitigation strategies
Facilitating regular project meetings to plan or review project scope, assumptions, timelines and activities
Being primary point of contact for all stakeholders
Budgetary and schedule management
Maintaining a timely flow of project information
Assessment of project against key performance indicators
Preparation of all status reports
Vendor management and payments
Ensuring all involved parties are properly trained. Coordinating ongoing trainings.
Precisely accurate and timely statistical data is critical to the progress of your trial from one stage of development to the next. It provides the bedrock to your clinical study report and forms the basis for your financially impactful decisions.
Through our global partnering network we provide access to leading biostatistics experts who work to ensure the integrity of your data complies with the latest international standards and is matched by equally robust analysis, digestible presentation and actionable insight. As an example, we frequently help USA based sponsors to conduct studies in Europe. We then produce data under FDA requirements so the analysis and results can be successfully submitted to the relevant USA authority as well.
Input in study design
Development of statistical analysis plan
Sample size calculation
Randomisation (envelopes and IXRS)
CDISC, data mapping programming for FDA submissions
Delivery of TFL Reports
CSR preparation as per ICH Part E3
Creation of DSMB (Data Safety Monitoring Boards) Chart
Allocation of statistical profiles for DSMB purposes.
Planning and executing a successful clinical trial demands a considerable investment of resources and its potential impact can be considerable for sponsor organisations and patients alike. It is vital that all your study documents are clear, accurate and compliant– and produced in an efficient and timely manner.
Our cohort of expert medical writers cover various therapeutic areas and assist with the delivery of a wide range of documents from patient information sheets to full clinical study reports. They are also supported by our meticulous review processes and quality control teams to make sure everything is drafted to meet international regulatory standards.
Clinical study protocols (creation and review)
Investigational Medicinal Product Dossiers (IMPD)
Clinical study report (CSR)
Abstracts, posters and scientific presentations
Manuscripts for Journals submission
Literature search and reviews
Patient education materials
Informed consents and assents
Medical Consultancy and Support
Study design and strategy support
Allocation of expert physicians (specific indications or therapeutic areas) to help on the protocol design and study strategy
Patient safety is our foremost concern. We deliver a comprehensive array of safety services for clinical trials of drugs, medical devices and advanced therapies across any European country.
Creation of Safety Management Plans (SMPs)
Creation of tailored safety database and safety forms
Safety data entry
Individual Case Safety Report (ICSR) management and elaboration of narratives
Mandatory expedited and periodic safety reporting to health authorities and ethics committees
EMA EudraVigilance portal: client and study registration
Reporting to DMC / Sponsor
Reconciliation of SAEs
Safety data review per patient
Safety vigilance 24h availability
I would like to thank you all for the tremendous work done to reach this important milestone for the study in a very challenging and complex global environment. It is the first of many others that we will have to achieve together. Let's keep it up!
Clinical Project Leader, Big Pharma Company
We are very grateful for your hard work and dedication over the past few years. We are delighted to be part of this partnership and look forward to start treating patients in this new therapeutic area soon. We could not have done this without your contribution. We are very excited about the path ahead and can hardly wait to start this study.
Chief Executive Officer, Biotech Company
Corporate team and I would like to sincerely thank all the team members, both global and local, as well as the site staff, who have worked extremely hard to reach this lock! This has been achieved under difficult circumstances, being significantly earlier than planned for this discontinued study and in the middle of the COVID-19 pandemic with lockdowns or curfews in place in many of the countries. A huge thank you to all for your team spirit and commitment to reach this goal!
Clinical Project Lead, Big Pharma Company
Very pleased. Looking forward to getting the country up and running soon.
VP Global Clinical Operations, Medical Device Company