CONTRACT RESEARCH AND CONSULTING ORGANIZATION
 
 

Consulting

Introduction

 

 

“It is not enough to do your best; you must know what to do, and then do your best.” Edwards Deming

 

There are different factors behind corporate successes. To be successful the company leaders must be aware of what they do, why they engage in work, what path they want to take, with whom they should work and what the results of their work should be. Continuous improvement, the ability to adjust to business environment and market trends are the qualities of a  modern, effective organization. Clinmark can help to develop your business. Our consultants have a unique combination of business, operational and research quality standards expertise. We can support you in planning research programs and projects,  the optimization of research processes, vendor selection, oversight of the project execution, project quality measures, risk assessment and risk mitigation plans. Due diligence evaluation, regulatory inspection, tutoring and operational expansion to new territories are key elements of Clinmark’s consulting services. Our expertise covers  over 200 consulting projects performed in 48 countries on 5 continents. The choice of Clinmark’s consulting services guarantees  fresh and in-depth insight in  you organization,  professionalism, dedication and personalized solutions.

 

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Please contact Clinmark to find out more on how we can help you.

Quality Assurance

 

 

Mock inspection

 

Regulatory inspections of clinical trials are an integral part of pharmaceutical industry life. FDA and EU drug regulations require from the drug license owners to collect and submit information on efficacy and safety of their products, but also give the authorities the right to inspect the information provided. Clinmark’s professionals have helped our clients many times to get prepared to and successfully go through the regulatory inspections. Our expertise consists of a pre-inspection gap and weaknesses identification in the research processes and research documentation, mock inspection of investigational sites and Sponsors’ departments, training of investigators’ and Sponsor’s staff, hosting the inspection on Sponsor behalf, preparation of responses to inspection observations and last but not least, the implementation of CAPAs. We have performed more than 40 projects, connected with regulatory control, in various regions of the world, getting our clients prepared for both FDA and EMA inspections.

 

 

Preparation for Regulatory Authorities Inspection

 

Clinmark offers comperehensive support for preparation for GxP inspection tailored to the needs and expectations of a Client. The GxP audits are conducted by Clinmark’s experienced auditors. Receiving EU GMP Certification is highly valuable for companies, because it gives them a competitive advantage and confirms, that they manufacture compliant high quality drugs. Clinmark performs GMP audits at a number of plants around the world to ensure compliance with GMP guidelines and covers a lot of products.

 

 

 

GCP audits

 

Quality assurance plays an important role in the clinical research. The independent audit gives the objective insight into the clinical research projects and provides objective information about credibility/compliance of the research data and efficacy of operational processes including project monitoring and management, safety, data processing. Clinmark has performed over 130 GCP audits in 46 countries worldwide. We have been working in almost all therapeutic areas in projects of investigational medicinal products, vaccines and medical devices. Our GCP audit service includes audits of investigational sites, project management, data management, TMF and vendors.

 

 

GMP and GDP audits and consulting

 

Our consultants have extensive knowledge and experience in all aspects related to quality management and quality assurance in particular with the requirements of GMP, GDP.  We can assist you in:

 

  • preliminary audit and analysis of Quality Assurance System documents.

 

  • elaboration and implementation of necessary documentation of Quality Assurance System according to Good Distribution Practice.

 

  • audit of technical documentation, elaboration and implementation of Validation Policy

 

  • transport cost analysis, profitability of transport routes

 

  • performing of GMP audits of medicinal products manufacturing plants

 

 

Preparation for Regulatory Authorities GMP Inspection

 

Clinmark offers comperehensive support for preparation for GMP inspection tailored to the needs and expectations of a Client. The GMP audits are conducted by Clinmark’s experienced auditors. Receiving EU GMP Certification is highly valuable for companies, because it gives them a competitive advantage and confirms, that they manufacture compliant high quality drugs. Clinmark performs GMP audits at a number of plants around the world to ensure compliance with GMP guidelines and covers a lot of products.

 

 

SOP development

 

Part of Clinmark’s consulting offer is devoted to the development or review of SOP system. With the expertise gained by performing over 200 consultancy projects and reviewing thousands of operating procedures, we can offer development of the SOP system or optimization of the existing one. Prior to implementing SOP development service, we always start with understanding of client’s operational processes, to develop SOP systems that fit best clients’ expectations and business operations.

 

Our offer includes:

 

  • support in preparation of study sites or headquarters of our clients for FDA or EMA inspections or support during the conduct of the above-mentioned inspections

 

  • assessment of client’s study documentation

 

  • identification of gaps

 

  • conduct of any type of audit – from study site audits, TMF, laboratory and vendors audits, audits of Data Management, Project Management and study reports to process and system audits.

 

  • support in writing and optimizing SOPs

 

  • consulting and support in creating or reorganizing clinical trial departments and quality departments

 

  • help in planning additional activities essential to preparing a complete dossier

 

  • optimal selection of subcontractors

 

Please contact us for more

Please contact Clinmark to find out more on how we can help you.

Clinical Research Consulting

 

 

Expansion to new territories

 

In the world of globalization and increasing competition, a smooth and qualified conduct of clinical trials is becoming more and more challenging. One of the solutions to this challenge is venturing into new territories, in terms of projects execution, which are more attractive as for recruitment or cost-efficience. However, the expansion to the unknown regions is connected with the increased risk of failure. Clinmark can help you make conscious decision about the expansion, plan and implement the expansion wisely and minimize the risk. We have the experience in conducting over 70 due diligence and mock inspection projects worldwide; in Central and Middle Europe, Africa, Middle East, Asia. In addition, we have extensive experience in GCP audits and Quality Management System consultancy. Execution of so many projects has enabled Clinmark’s consultants to acquire solid understanding of the clinical research processes, research quality, US, EU and local regulation requirements.

 

Due diligence

 

Prior to business merges or acquisitions, we perform the assessment of a company to be acquired or merged. The appropriate, thorough evaluation and analysis of the company’s research pipeline, know-how and operational performance are part of the due diligence audit. People at Clinmark have competences to perform complex due diligence audits of biotech and pharmaceutical companies. In the due diligence process we assess the ongoing and planned research programs of the compounds in the pipeline, efficacy of operational processes, business threats, risks and limitations. Our expertise consists of over 30 due diligence projects done up to date. We performed due diligence audits of CROs, biotech companies and SMOs in Europe, Middle East, Asia, Africa and US.

 

Our service of expansion to new territories is directed to both CROs and biotech/pharma companies.

 

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Please contact Clinmark to find out more on how we can help you.

Medical and Scientific Affairs

 

 

Clinical Development Plan

 

 

If you are just starting to plan your product/ device development or you want to explore European market to authorize your product in EU or outside EU European countries, our experts can guide you through the initial processes to help you to collect knowledge to plan your short-term and long-term activities  and budget required for successful product/ device authorization. To make your development path easier we can provide you with a medical and regulatory expertise, including the epidemiology and standards of care information, preliminary study design, sample size calculation and budget as well as regulatory requirements for market authorization or certification.

 

 

Protocol Design Thinking

 

Our qualified team that includes a medical expert(s),biostatistics, medical writer and operational representative can support your product development through designing the right protocol to address the right scientific questions. Based on a deep understanding of your business model and needs, the regulatory environment, main competitors and your specific scientific questions, we can:

  • Help you plan your study design and perform early stage feasibility study
  • Help you develop the efficient study protocol with relevant eligibility criteria, study assessments and endpoints
  • Assess regional clinical practice, epidemiology and competitive study activity in various targeted countries to support country and site selection
  • Connect with investigators and key opinion leaders

 

 

Study Documents Development & Medical Writing

 

When your study protocol is ready or advanced enough, our experienced medical writers can develop key protocol-based study documents required for effective study start-up:

  • Protocol-Specific Patient Information and Informed Consent Form to allow for your patents consenting and using their medical data for study purposes
  • Case Report Form content to allow for either electronic or paper-based CRF design

 

 

Medical Monitoring & Data Review

 

We are ready to support the process of clinical data collection for your study via medical monitoring & data review. Our medical monitors will proactively work with investigators to ensure proper execution of the clinical trial protocol from medical point of view and they will support investigators’ continuous interest and motivation to ensure effective recruitment of patients. They will also be responsible for regular safety data review as well as verification of medical consistency of the delivered data.

 

 

Study Results Description & Presentation

 

When the expected study is collected, cleaned and the data base is locked our scientific team is ready to analyse the data and process study results. The team consisted of biostatistician, study medical expert, and medical writer will develop the Clinical Study Report describing the process of protocol execution and the achieved results as well s the main results driven conclusions which will become the basis of your scientific publications as well as further scientific and marketing decisions of your product life cycle.

 

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Please contact Clinmark to find out more on how we can help you.

Coverage

 

 

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Please contact Clinmark to find out more on how we can help you.

Product Development Plan

In order to bring a new drug to the market, pharma or biotech company will require a partner ready to provide one to establish a Product Development Plan.

 

Clinmark Consulting Department supports clients on very early stage of product development by providing an optimal regulatory path and creating Product Development Plans that gives a practical knowledge, which trials should be performed for the specific product or Clinmark’s experts provide such expert advice in all areas of Product Development, starting from preclinical strategies, regulatory advice, study design and protocol preparation through other parts of a product development process.

 

Clinmark’s consultants have wide therapeutic expertise and broad understanding of local and global market requirements, regulatory guidelines. Clinmark has wide experience in the development of medicinal products, as well as of medical devices and food supplements.

 

For last 10 years Clinmark’s experts have been working on many regulatory activities such as regulatory Roadmaps and Feasibility Assessments, Non-clinical Development Plans and Product Development Plans, orphan drug designations, dossier writing and general regulatory assistance. Clinmark’s consultants have prepared regulatory roadmaps and scientific assessment for several pharmaceutical products for different indications: cervical cancer, colorectal cancer, enterohepatic cancer, breast and ovarian cancer, rare diseases. Besides, Clinmark has participated in Pancreatic and Ovarian Cancer ODDs in EU and USA, and we worked with Chemotherapy drug preparing clinical modules of the product dossier.

 

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Please contact Clinmark to find out more on how we can help you.

Product Registration

Clinmark’s team has extensive expertise regarding Regulatory Affairs and is always ready to support Sponsors in all regulatory aspects. Our experts assist the Customers in development of regulatory strategy for:

  • medicinal products,  
  • food supplements,
  • veterinary products
  • medical devices.

 

Procedures

Clinmark’s team evaluates existing documentation in order to manage marketing authorisation process through one of these procedures available in the EU:

  • National procedure
  • Centralised procedure
  • Decentralised procedure
  • Mutual recognition procedure

 

Clinmark can provide advice from dossier preparation and submission through marketing authorization support (also for companies from non-EU countries).

Clinmark’s consultants can guide the Clients through the whole regulatory process and provide one with full-service solutions at any stage of product development.

Clinmark has already handled a lot of such projects for Polish and foreign Sponsors (Iranian, Ukrainian, Russian).

 

eCTD characteristics

Moreover Clinmark provides services for CTD/eCTD (Electronic Common Technical Document) compilation. The CTD is organized into five modules. Module 1 is region specific, while modules 2-5 related to technical document summaries, quality, non-clinical and clinical study reports are common for all regions. The process of eCTD compilation takes a lot of time. So outsourcing of these activities to a trusted partner is the best solution. Gap analysis of data and documents will guarantee eCTD readiness and give a Customer flexibility to allocate resources to other projects, while Clinmark team will do all the best to launch a product without delay.

 

Please contact us for more

Please contact Clinmark to find out more on how we can help you.