Global Clinical Operations
“It is not enough to do your best; you must know what to do, and then do your best.” - Edwards Deming
Clinmark’s experienced, highly committed team implementing quality standards to meet the requirements of health authorities has been providing high-quality clinical research services for almost two decades. Clinmark’s business model focused on conducting full profile, international projects more effectively than global CRO by optimal selection of countries and validated Partners from our Network of local CROs. Strategic planning, exact schedule and identification of relevant countries, sites and investigators play a major role in defining success of the trial execution. We perform initial assessment of optimal country and site selection based on epidemiological data, protocol feasibility, regulatory requirements, define patient recruitment and retention strategies and identify risk factors. We guarantee excellent and quick subject enrollment with optimal budget.
Investigator Initiated Trials
Phase I-III Clinical Trials
We provide full-service solutions for phase I-IV clinical research in all therapeutic areas with each study undergoing a customized approach and oriented on the preparation of our customers for their success.
We provide comprehensive experience in conducting non-interventional studies enables us to manage and support the entire process from planning any study to creating the final report.
Medical Device Trials
Clinmark provides customers with full service medical device trial conduct, starting from the protocol writing, through data monitoring, medical monitoring, project management and preparation of the final report.
Bioequivalence and Bioavailability Studies
Clinmark’s flexibility, commitment and high quality standards make us the perfect partner. We are a reliable and experienced CRO specializing in full range of clinical research projects such as:
Bioequivalence (BE) and bioavailability (BA) studies – Bioequivalence and bioavailability studies are conducted in strict compliance with EMA, FDA and other local regulatory authority requirements.
Pharmacokinetic (PK) and pharmacodynamic (PD) studies - Clinmark provides PK or PD data analysis as part of clinical trial services or sometimes as a stand-alone service. Clinmark’s experts provide clients with the knowledge and data needed for one’s clinical trial success
As a company dedicated to comprehensive planning and organization of phase I – IV clinical trials, prior to the executive part we offer drawing up and preparing documentation that is essential to conducting clinical research. Appropriate planning of the study and well-prepared documentation are the key elements contributing to the proper conduct of the entire process.
Study budget and schedule
To perform successful clinical study it is important to prepare and maintain the budget according to the Customers’ financial needs of conducting a trial. Clinmark creates the budget based on available Clinical Study Protocol and timelines agreed which is comprehensive and defensible. The budget includes all direct and indirect costs anticipated in the study. During developing and negotiating budget structure and terms, Clinmark always keeps in mind that transparency and collaboration that balances the with Customer's goals, issues and priorities are the key to win-win negotiations. That is why Clinmark always works together with Customer to ensure a mutually beneficial economic arrangement in which everyone benefits.
Clinical Study Protocol is the document that describes the research question, the rationale for the study, the main objectives (outcomes), the design and organisation (study management and oversight), statistical considerations, methodology, safety and risk management procedures, and plans for publication at the end of the study. Clinmark Team supports protocol development process. Our assistance covers a wide-range of therapeutic areas as well as protocol template adaptation according to the international standards, protocol writing, statistical support and independent medical consultation, if needed.
Study Documents Development
Our writers’ strong scientific backgrounds, knowledge of GCP and ICH guidelines and experience in wide variety of therapeutic areas ensure that we’re complying with all regulatory guidelines and accurately presenting study results, and providing clear and accurate documents.
Clinmark’s medical writing services can support Customer’s documentation needs throughout the entire lifecycle of one’s clinical trial. Clinmark can provide you with the following documents:
Clinical study protocol and amendments
Patient Informed Consent Forms
Case Report Forms
Clinical Study Reports
To identify and select the appropriate vendor is to establish of the business goals firstly. Once the projects parameters are defined clearly it is the first step to select and manage vendors to compare and assess. Clinmark selects the best vendors that are able to match Clinmark company’s performance characteristics. Because every vendor has its strengths and weaknesses, choosing the right one is a very critical task to optimize operational results.
Well-executed feasibility allows the Sponsor to avoid a lot of difficulties related to the study, such as trial delay, missed timelines, poor patient enrolment. Clinmark’s dedicated and experienced team accurately analyzes and reviews sponsor’s concept and plans regarding the trial execution. Based on the relevant data, our experts recommend countries, sites and potential investigators. Due to Clinmark’s accuracy and predictability the smooth recruitment of the subjects and on-time finalization of the study are guaranteed. Every project managed by Clinmark is given through comprehensive assessment, taking into consideration medical, epidemiological, clinical, regulatory and logistical issues.
We are aware of how important for our partners a swift start-up of a clinical trial is. We support you in organizing the preparatory phase of a clinical trial in a given country, aiming to achieve high efficiency in reducing the time window of protocol approval and the first visit of the first patient in the study. We check thoroughly the feasibility of a clinical trial in a country or region. Our extensive experience and a significantly vast network of contacts of potential investigators help us assess the real possibility of study sites to recruit patients and optimize the process of choice, bearing in mind how important it is to obtain complete, accurate and reliable data from the study.
Regulatory submissions are the most critical milestones in the clinical study. National regulations influence the submission and timelines. There are significant differences between countries and sometimes even within countries between local Ethics Committees, in the way they work and what they require. Prior to study initiation, Clinmark ensures that all required essential documents are collected, reviewed, and approved per regulatory requirements. Clinmark’s dedicated team provides a comprehensive range of submission and approval-related services for the customers. We can assist in efficient communication, including:
Compiling submission packages
Competent Authority submission
Ethics Committee submission
Local hospital board approvals
Other relevant permission
Study amendments and study termination
Full-profile Project Management
Clinmark’s experienced project managers successfully supervise both local and international clinical trials. Their in-depth knowledge and risk assessment skills, commitment and experience ensure a smooth conduct of any clinical trial. Assessing real time risks they make sure that the necessary corrective and preventive actions are implemented at the earliest possible stage of a project. Project management also includes optimal selection and supervision of local contractors.
Clinical Monitoring & Administration
Clinmark’s monitors have a role of a “communication bridge” between an investigator and a sponsor, supporting research sites. Monitor’s activities are of high quality and efficiency due to strong emphasis on time management skills, effective communication in the remote working environment, auto-coaching and regular knowledge and experience sharing.
Clinmark offers various models of monitoring: on-site monitoring, targeted / remote monitoring and risk based monitoring depending on client’s needs, degree of difficulty and level of risk in a particular study. Regardless of the type of monitoring, our goal is to ensure compliance with the study protocol, ICH-GCP Guidelines, local regulations and SOPs, ensuring accurate and reliable data and objective assessment of the investigational medicinal product or medical device.
Critical for study success will be appropriate site selection, management and contact with site staff in order to achieve study startup and enrollment timelines. Clinmark has access to and relationships with a number of highly respected sites with proven experience in various therapeutic areas and operational knowledge, efficient start-up, accessible patient populations, and a history of successful execution based on our direct team member interaction. That’s why Clinmark can commit to achieving patient enrolment targets within fixed timelines.
Vendor management is about improving the process for increasing efficiencies and managing vendor relationships to ensure that the agreements made are mutually beneficial for both parties. Oversight the vendors is a process that is critical throughout the life span of a clinical project. Ongoing oversight of vendors is conducted and is achieved through a variety of different methods. However the main point is to be involved in the project very deeply and have a strong knowledge about it. It increases a chances in discovering any issues and then finding the best solution to keep project moving in the right direction.
Quality Assurance & Oversight
Quality of the clinical trials conducted by our team cannot be compromised. That is why we continuously improve our service. We have prepared audits and oversight visits for our clients which assess monitors’ performance as well as the work of research sites, helping them find new and optimal solutions, if there is a need. Furthermore, we conduct audits of study documentation (TMF Audit) and subcontractors. Our team serve as a support in preparation of our partners for inspections.
Data Management and Biostatistics
Clinmark designs database systems tailored to client’s specific needs in order to ensure effective data entry. We support our customers in designing a study plan and sample size, creating a statistical design, selecting methods of analysis and carrying out partial and final statistical data analysis along with a report. Clinmark’s Team screens data for errors and deficiencies. After that queries are designed. Clinmark has extensive knowledge of electronic data entry systems (EDC) and ensures the integrity and validity of clinical trial data.
Clinmark’s biostaticians provide the customers with support in all phases of drug development. Clinmark’s team evaluates data in order to verify, that all procedure have been performed according to relevant biostatistical standards. We guarantee exact planning, collection and evaluation of the data.
We offer the following biostatistical services:
• Sample size calculation & Consulting statistical issue in the protocol development
• Statistical Analysis Plan(SAP) development with Mock Tables
• Analysis disposition
• ADaM dataset or Analysis dataset (double programming)
• TLF(Tables, Listings, Figures) generation/validation (double programming)
• Key results report
• Writing SAR(Statistical alaysis Report)
• Subject listings (CSR appendix)
• Archiving STAT documents
• CDISC ADaM/ define-XML / Reviewer's guide
Pharmacovigilance is critically important for drug safety and development. Our Pharmacovigilance Team and Safety Officers report and manage adverse events. Clinmark also prepares periodic safety update reports, annual safety report, risk management planse, responses to regulatory authority queries and other relevant safety-related documents.
DSMB – Data Safety Monitoring Board
Clinmark ensures patient safety through an independent panel of experts - Data Safety Monitoring Board who meet to review clinical data. We ensure an independent oversight of clinical safety data. Clinmark is experienced in supporting sponsors in the creation and management of DSMBs to monitor the safety of clinical trial.
Medical Monitoring and Data Review
Clinmark’s medical monitors have already monitored a lot of trials covering key therapeutic areas. Gained knowledge and experience allows us to apply innovative approach to clinical trials. Prior to the study our team provides consultation on study design, patient selection, endpoint issues, feasibility and site selection. Our medical monitor can also support you with comprehensive medical plan development. During and after clinical trials conduct Clinmark offers medical review of eligibility, assists pharmacovigilance activities, support monitors in medical issues.
IMP Manufacturing & Logistics
Clinmark is not only a CRO but also a specialized full-service provider. We offer flexible solutions to meet all your individual requirements. Our range of services includes:
Importing and exporting of IMPs
Labeling and packaging of products in the GMP zone
QP release and QP declaration
Controlled environment warehousing and transportation according to GDP.
Clinmark has the ability to source practically everything you need for your clinical trial.
3 Pillar Methodology
Clinmark offers three-pillar Functional Service Provision (FSP) model customized to Client’s needs, giving the opportunity to save on recruitment and training costs and to have access to quality people only when needed. Clinmark’s model focused on investing and attracting talented people allows the companies to be more efficient and flexible in conducting clinical trials. Thanks to such strategy companies can avoid various risks related to HR area and at the same time increase organizational effectiveness. The three-pillar FSP consists of:
Pillar I: Trainings, continuous improvement process
Pilar II: Constant Quality Control
Pilar III: Methodology and tools support
Clinmark’s FSP offers benefits such as increased productivity and quality within the study, flexibility of workforce and cost saving. There is also an ability to work real-time, a distinct advantage over traditional full service CRO.
Clinmark’s model focused on investing and attracting talented people allows the companies to be more efficient and flexible in conducting clinical trials. Thanks to such strategy our Clients can avoid various risks related to HR area and at the same time increase organizational effectiveness.