U Plynárny 1002/97, Prague 10, 101 00 Czech Republic

Input to the Clinical Development

Specializing in Regenerative Medicine and Cell Therapies. Focusing on EU, and the Central-Eastern Europe

Site Selection

The importance of a clinical trial’s success is mainly based on recruiting, contracting, and equipping sites and investigators for enrolment success. We understand the needs, challenges and dynamics of effective sites recruitment. We guarantee a quick site selection based on a competent, careful planning with solid demographic and infrastructure data, and using accurate past performance metrics. Our goal is to find the right sites, at the right time, to support delivery of effective study results.

A large database of clinical physicians and related references guarantees selection of the most appropriate investigational sites. Our training of the investigators ensures high quality performing of Clinical trials according to GCP.

Contract Negotiation

We assist to arrange Hospital contract, Investigator contract, and Laboratory or Pharmacy agreements according to national and EU legislation and requirements, in highly professional way, using excellent negotiation skills. The result is to provide you with the most appropriate and cost – effective solution.

Site Monitoring

Monitoring is a crucial element in trials, therefore we engage Clinical Research Associates (CRAs) that see a study through from start to finish. We only provide CRAs who have an outstanding background, and they implement motivational strategies and smart supervision.

Trial Monitoring

Clinical monitors have excellent reporting and communication skills. Qualities such as reliability, accuracy and motivation are highly emphasized.

Members of monitoring team are regularly trained in order to ensure perfect monitoring of Clinical Trials in accordance with:

  • Principles GCP
  • Country specific law and requirements
  • International guidelines
  • Study –specific requests (Protocol, SOP etc.)
  • In addition to performing on site visits (pre-study, initiation, monitoring, close out visits) f
    • Reviewing specific documents and translation
    • Ethics committee and regulatory authority submissions
    • Updating and maintenance of Investigator Site Files and shadow files
    • Monitoring subjects recruitment, source data verification, adverse event reporting
    • Controlling adherence to protocol, SOP and other regulations
    • Properly reporting sites status and issues to the sponsor
    • Presentations at Investigator meetings

Pre-study visits

The objectives of a pre-study visit are to review the adequacy of the site, the training and experience of the study staff, the access to the right patient population, and the site’s interest in the study.

Initiation visits

During the initiation visit, monitors are reviewing the study protocol, study design and answering questions from the site personnel. They discuss the Investigator’s Responsibilities as related to the regulations to ensure there is agreement and understanding.

Close out visits

Study close out visit is a final visit conducted after all subjects have completed the study and all data are recorded in case report forms (CRFs). The purposes of the visit are:

  • To ensure that all processes have been administered according to the protocol
  • To ensure that all documents regarding investigational product accountability are accurate, complete, and legible
  • To complete monitoring at the study site and return all completed CRFs to the Sponsor
  • To confirm the return (or final disposition) of all study-related material
  • To ensure that all regulatory documents are on file
  • To review Investigator’s responsibilities after termination activities have been completed

Project Management

The project management is addressed to a wide variety of stakeholders, from managers to board members, subordinates to clients and vendors. From an operational perspective, all the elements of the clinical trial are joined together in order to create one coherent project.

Risk Management

It is indispensable to always conduct a trial after evaluating all possible issues – ranked by probability and impact – in order to develop a comprehensive mitigation strategy.

Quality Assurance

Comprehensive and effective auditing, well-prepared operational management, precise metrics and business acumen, and a clinical trial audit should evaluate a complex set of systems.

Regulatory Approvals

The regulatory specialists are assessing whether the study is suitable for the local jurisdiction at the feasibility stage, then they provide a list of required documents, a process workflow and an official timeframe. Service providers are performing metrics, too – the number of recent submissions, their success rate, average duration of approval rates – to compare them with the national statistics from the regulatory body.

The experts team assures parallel submissions to regulatory authorities, local and multicentric ethics committees, and institutional review boards, including further communication and maintenance related correspondence.

Translation and Validation

Conducting studies in more than one country and in more than one language, make the translation to be a multifaceted affair. Equality and diversity in clinical studies is vital. Patient questionnaires, information and administration leaflets don’t just need to be translated though, they need to be trans-created to take account of the nuances of local culture as well as distinct jurisdictional requirements. Furthermore, while assessing the patient we need to be conscious of local norms. Being culturally sensitive is all part of the translation process.

Medical Writing and Safety

The results should be clinically (and socially) meaningful, as well as providing commercial value. Besides satisfying the regulators and the ethicists, both the study protocol and the study report ought to satisfy the public and the medical/scientific community.

Amending the protocol during the trial is expensive and creates unnecessary risks. Therefore, testing a protocol before work starts, and exposing it to review by the experts in the field, is such an important part of controlling quality and downstream cost.

Documents Could Include:

  • Clinical study protocols
  • Standard operation procedures
  • Manuals and templates for document standard
  • Clinical study report
  • Statistical services

We are able to completely cover the whole course of the project including final clinical report, ensuring consistency across the document as well as compliance with GCP, pharmaceutical and regulatory requirements. Appendices to clinical study reports consist of the largest component of many regulatory submission dossiers and require very precise professional approach. We ensure that GCP principles and ICH compliance will be carefully observed.

Data Management and Statistics

The presentation of information is as valuable as its content. Often, the electronic systems currently used in trials are cumbersome and slow, with data protection and commercial security considerations for operating systems that encourage inconsistent data entry and confusing reporting. We have specific tracking system for queries, each database entry is verified, discrepancies are solved by queries issuing by Data Manager and solved by Medical advisor or investigator. Each query is documented, tracked and entered into database.

We believe in excellent data visualization that provides smart, easily understandable, and even beautiful results that mean that analysis can take place in shorter time frames and to smaller budgets.

Documents Could Include:

  • Statistical consulting
  • Trial design
  • Sample size estimation
  • Randomization
  • Statistical analysis plans and presentations for regulatory authorities
  • Regulatory affairs including submissions to the State Institute for Drug Control and to local and central Ethics committees

Own hospital network

BioniX Ltd. Is a service provider CRO, based a vast network of own/in group (more than 45 hospitals and clinics), 10 000 sqm od new cGMP labs dedicated for cell and tissue based products in Czech Republic, Poland and Slovakia:

The network is founded by the join forces of three pilans in the above countries:

  • Penta’s Hospitals in Czech Republic
  • Svet Zdravia in Slovakia
  • EMC Chain in Poland

The network fully operational already has the ambition to triple sales by 2025 based on best practices and innovation. More specifically:

1. Penta’s Hospitals / Czech Republic

  • 4 Regional Hospitals
  • More than 4,000 Employees
  • 900 Bed
  • Clinical Research in:
    • Internal medicine
    • Cardiology
    • Ophthalmology
    • Neurology
    • Psychiatry

2. Svet Zdravia / Slovakia

  • 17 Regional Hospitals
  • More than 6000 employees, among them 815 Medical Doctors / 2400+ Nurses
  • 4100+ Beds
  • Hospitalized >140.000 and Operated >28.000 patiends
  • Turnover of 166 m. € with an Investment of 40.6 m €

3. EMC Chain / Poland

  • The biggest network of private hospitals in Poland – 10 hospitals and 26 clinics
  • Services rendered for over 1 million patients annually
  • 4100+ Beds
  • More than 1 700 beds – four main wards constitute 57%
  • 9% revenues are from the NHF and 11% from commercial services
  • More than PLN 100 million capital invested.