CONTRACT RESEARCH AND CONSULTING ORGANIZATION
 
 

Clinical Trial Operations

Experience

We have conducted more than 210 clinical trials phase I – IV in almost all therapeutic areas.

 

Study-phases2

 

In addition to clinical trial organization, registration and monitoring, we have prepared protocols, amendments to the protocols, as well as final reports in a number of our projects.

 

Our experience in figures:

 

  •  We have conducted a total of 210 clinical trials.

 

  •  18 800 patients have been recruited by our team.

 

  • High quality of projects conducted by us has been confirmed in more than 20 audits performed by Sponsors in the sites monitored by us and in our office, as well as during inspections with final reports showing no significant findings.

 

We have conducted clinical trials and non-interventional studies in majority of therapeutic areas. Our vast experience covers in particular clinical trials in oncology, haematology and rheumatology.

 

Scope of activities:

 

  • Up to date, we have conducted a number of projects with drugs that have special storage requirements (biologics, TNF inhibitors, interferon, growth hormone, clotting factors, oncological drugs, vaccines).

 

  • We have knowledge of the regulations and procedures of handling narcotic drugs.

 

  • We have a unique and extensive experience in conducting medical device trials .

 

Therapeutic-areas4

 

Achievements

The largest global study, being managed by our team, is conducted in 19 countries with a total of 4800 enrolled patients.

 

The largest interventional studies conducted by Clinmark on Polish territory:

 

•  A phase III clinical trial in the end-stage renal disease (dialysis patients) conducted in 14 sites, including about 150 patients. The study was initially scheduled for 6 sites and 60 patient, however, due to recruitment problems in other countries, the recruitment commitment in Poland increased twofold owing to our engagement and determination, which eventually gave us 2/3 of world recruitment.

 

• Yet another example could be the study of phase II cancer (breast cancer), in which we achieved 160% of planned recruitment.

 

• Two projects in haematology; phase III trials, where Poland was a leader of recruitment, reaching respectively 50% and 35% of the world recruitment. In the course of study, the Polish site underwent FDA inspection, which did not reveal any significant discrepancies.

 

• Our largest non – interventional project was a study of 185 sites and 1850 patients.

 

• We planned and successfully conducted a non-interventional medical device study of 736 patients, providing full support to our partner; from the protocol design, throughout supervision and monitoring of the project to the final report, fully embracing very strict time lines.

 

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Please contact Clinmark to find out more on how you can benefit from our cooperation.

Research Documentation

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, such as: protocol, patient informed consent form, CRF as well as medical records. Appropriate  planning of the study and well-prepared documentation are the key elements contributing to the proper conduct of the entire process. That is why we make sure that our  customers are provided with high-quality documents which are optimized, internally consistent, and compliant with standards, so as to avoid any potential problems in the course of clinical trial. We also provide support in the preparation of the final report. Depending on our clients’ needs, we may create documents in different languages, adapting them to the local requirements.

 

Study Start-up

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. We support our partners in the process of contracting sites as well as local vendors, and we are responsible for the research teams training process, preparing staff to conduct research in compliance with the protocol, ICH-GCP regulations, law and SOPs.

 

Registration of Clinical Trails

In accordance with harmonized standards, local laws and EU directives registration of clinical trials is to be done by the relevant health authority, e.g. In Poland, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products by the Ministry of Health is the administrative body responsible  for registration of clinical trials. Moreover, the positive opinion of the Ethics Committee is to be obtained. To meet our customers needs, we complete documents essential for submission to the relevant authorities and the ethics committee, fill out the application documents as well as ensure due diligence of the entire process in order to obtain the approval for the clinical trial conduct within the time frames specified by law. On behalf of the Sponsor we are responsible for the communication process with the Bioethics Committee and health authorities representatives, as well as the process of submission throughout a clinical trial, and last but not least mandatory reporting including, but not limited to, progress reports.

 

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Please contact Clinmark to find out more on how we can help you with your Study Planing and Preparation.

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. Using the principles of strategic leadership, our team provide high expertise throughout a trial in all sub-teams. At the request of our clients we create a dossier that supports the organization, logistics and the conduct of individual processes in a study.

 

Clinical Monitoring & Administration

Due to demanding training and development programs ensuring high awareness of responsibility and the ability to prioritize tasks, Clinmark’s monitors take 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.

 

Clinmark’s service also includes outsourcing of qualified monitors, working directly under our client’s supervision.

 

IMP Manufacturing & Logistics

We can provide flexible and responsive solutions to help overcome your IMP manufacturing and clinical supplies challenges from packaging design through labeling, storage, quality control and release to clinical supplies management. We use time saving customer-tailored solutions to meet your specific needs and time-lines and finally help speed your trial to success. 

 

We offer specialized transportation service for pharmaceutical industry in entire Europe. High class and qualified vehicles guarantee safety of the products during the transport in controlled climate conditions (temperature and humidity). All our vehicles and transportation procedures fulfills requirements of Good Distribution Practice.

 

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Please contact Clinmark to find out more on how we can help you with your Study Execusion.

Observational Studies

Our 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. At the request of our clients we create a complete documentation of study (protocol, patient Informed consent form, CRF, documentation for patients and documentation related to the management of study), we maintain the relationship with key opinion leaders, perform the oversight of on-going research, as well as provide data management, research reports and the support of publication process.

 

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Please contact Clinmark to find out more on how we can help you with your Observational Studies.

Medical Device Trials

Our understanding of the regulatory differences regarding the conduct of medical device trials enables Clinmark to provide our business partners with full service of medical device trial conduct, starting from the protocol writing, through data monitoring, medical monitoring,  project management and finally preparation of the final report. We are one of few CROs in the region with such extensive experience in conducting medical device trials which allowed us to build a database of potential research sites, particularly  in the area of​​cardio-vascular diseases and cancer diagnostics. Compliance of the study with its endpoints, all the requirements and regulations, including ISO-14155-2011 is our priority.

 

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Please contact Clinmark to find out more on how we can help you with your Medical Device Trials.

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.

 

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Please contact Clinmark to find out more on how we can help you with Quality Assurance & Oversight.

Data Management & Biostatistics

Owing to the strong partnership, we can provide our clients with a high quality service of data management and biostatistical analysis. We support our clients in designing a plan of study and  specifying study sample size, creating a statistical design, selecting analysis methods and carrying out partial and final statistical data analysis along with a report.  Data can be managed using either paper or electronic CRF. Additionally, at the request of our clients we can provide eCRF access and design based on known platforms, as well as database design, study set up, clinical coding, real-time data management, data verification including medical verification and data cleaning by qualified personnel.

 

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Please contact Clinmark to find out more on how we can help you with Data Managment & Biostatistics.

Functional Service Provision

Clinmark offers three-pillar-functional service provision 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 functional service consists of:

  • Pillar I: Trainings, continuous improvement process

     

  • Pilar II: Constant Quality Control

     

  • Pilar III: Methodology and tools support

 

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.

 

Three-pillar FSP benefits

TOP 7 benefits of the three-pillar functional sourcing have been presented below:

  1. Flexible solutions tailored to Client’s needs
  2. Ensuring trained and proficient resources
  3. Allowing to focus on core business
  4. Increasing flexibility of Client’s activities
  5. Improving efficiency and productivity
  6. Higher quality and greater cost savings
  7. Better long-term strategic planning

 

Outsourced jobs functions

Clinmark offers Staff for the following job functions:

  1. Clinical Trial Assistants and Clinical Trial Administrators (CTA)
  2. Clinical Trial Monitors (jCRA, CRA, sCRA)
  3. Clinical Trial Managers (CPL, CRM)
  4. Quality Control Specialists
  5. GXP Auditors
  6. Regulatory Affairs Specialist (RAS)

 

 

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Please contact Clinmark to find out more on how you can benefit from our cooperation.

 

QBD Feasibility

Our comprehensive QBD (Quality By Design) FEASIBILITY support will give you reliable data to bring effectiveness to the whole process of your trial so that you don’t need to struggle with back-up and rescue plans.

 

Through experience with a diverse client base, Clinmark has developed a unique approach for feasibility process both on the country and site level. We know that every Sponsor demands accelerated timelines, measurable results and reliable data. The QBD FEASIBILITY methodology is focused on effectiveness measured by the time to response, the number of sites with positive reaction, reliable assessment of potential patient population for the study, and the quality of data gathered in the process that are crucial for the future success of the project.

Feasibility tools developed by Clinmark define high quality feasibility data by:

  • selection of sites led by committed Investigators with professional teams – it allows not only a fast initiation of a trial, but also its smooth conduct and closeout
  • reliable data regarding enrollment commitment
  • complex approach that guarantees selection of the best investigators among all available
  • optimal time for a complete response to the Sponsor

 

 

QBD Feasibility types
We provide our clients with three types of QBD feasibiity according to study feasibility data requirements and best fit for specific clinical trial stage

 

1. Basic QBD feasibility

Gives you a quick, reliable and brief view on the potential of investigational sites to perform the study and estimate of enrollment possibilities.

 

2. Full profile QBD feasibility

By using advanced tools we provide you with precise, solid data enabling to accurately predict enrollment curves. We gather for you contact details of investigational sites and accompanied essential documentation that is subsequently incorporated to your Trial Master File.  Clinmark works with clinical sites to identify issues that may affect recruitment, execution and/or patient retention and also protocol design areas that may affect study execution. We also review the competitive landscape to identify other clinical trials aiming on the same or similar patient population.

 

3. High level QBD feasibility

Our consultancy experience allows us to support and advise Sponsors at an early stage of trial design, when decisions need to be made on regions / countries that will best fit the IMP program or single protocol design. In such cases the following environmental factors need to be analyzed:

  • Population / Epidemiology
  • Access to patients
  • Country-specific national healthcare system
  • Local standards of treatment of disease under study
  • Regional / country-specific regulations influencing study conduct including trial registration processes and timelines
  • Specific local requirements (i.e. related to Phase I studies, Medical Device trials)
  • Logistic conditions

 

We gather all necessary data to perform risk-to- benefit analysis of the above mentioned factors at an early stage of the trial. Our summary report and its recommendations written by Clinmark experts allow you to make optimal decisions that will significantly increase the chance for successful and timely trial delivery.

 

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Please contact Clinmark to find out more on how you can benefit from our cooperation.

Preclinical studies

 Preclinical research aims to pre-assess the safety and efficacy of a potential drug before it is first used in humans. This is the initial phase of research on the drug, assessing its effect on cells (in vitro) and animal organisms (in vivo).

 

Information from non-clinical studies is used in the planning of clinical trials involving humans. It is used to determine the initial dose and range of doses to be tested. It also suggest what clinical signs should be sought for detect possible side effects.

 

Clinmark provides full range of pre-clinical services covering pharmacological, toxicological and other tests depending on the type of product and the needs of our Client.

 

Our company offers high quality services that are in compliance with applicable law, guidelines of the European Medicines Agency (EMA), ISO Standards and Standard Operating Procedures (SOPs) created by CLINMARK experts. Knowledge of the law and guidelines allows to minimize the time and costs connected with the registration and testing, as well as the commercialization of the results of the work carried out.

 

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Please contact Clinmark to find out more on how we can help you with your Study Execusion.

Bioequivalence and bioavailability studies

Clinmark’s flexibility, commitment and high quality standards makes them the perfect partner for Client’s clinical research projects. Clinmark is a reliable and experienced CRO specializing in full range of clinical research projects such as:

 

  • Early phase studies – In order to establish one’s clinical development success, Clinmark’s experts do their best to move Client’s projects through early clinical development as soon as possible
  • Bioequivalence (BE) and bioavailability (BA) studies – For the smooth execution of studies which play a major role in the development of new drugs and their generic equivalents Clinmark’s experts plan the studies properly in accordance with requirements. Bioequivalence and bioavailability studies are conducted in strict compliance with EMA, FDA and other local regulatory authority requirements. Clinmark is cooperating with several early phase sites able to perform clinical research studies on healthy volunteers as well as patients.
  • 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;

 

 

Bioanalytical services – Clinmark provides the Clients with a full range of bioanalytical solutions in order to support them from early discovery to clinical research projects.

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Please contact Clinmark to find out more on how we can help you with your Bioequivalence and bioavailability studies.

Clinical Trials Supply & Logistics

Supply & Logistics

Clinmark has wide experience in supplying clinical trial materials and investigational products to the sites around the world. Clinmark’s experts ensure that all materials are collected in a quick and efficient way within the adequate temperature. Clinmark’s team uses the most efficient shipment to guarantee the success of an every clinical trial.

Comparator sourcing

Comparators are essential to the success of your clinical trial, and we understand that.

Clinmark’s experienced and dedicated sourcing experts are able to collect each pharmaceutical product directly from manufacturers or through trusted partners. Does not matter whether you need small or large quantities, with or without CoA, sourced from one single lot with a maximum expiry date according to your study needs.

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Please contact Clinmark to find out more on how we can help you with your Clinical Trials Supply & Logistics