Clinical Services

Cromos Pharma can management both single- and multi-center trials, in a wide range of therapeutic areas.

Cromos Pharma’s project management team is proactive, with effective communication across the spectrum. Responsibilities, processes and reporting lines are clearly defined at an early stage. These procedures are approved step by step to ensure complete transparency.

The primary point of contact will be the Project Manager who will give your study absolute priority, ensuring that timelines are met, quality is maintained, appropriate training is delivered and the budget is adhered to.

Experienced physicians monitor clinical trials. They are citizens of the respective country, fluent in English and have good knowledge of the local medical community and therapeutic standards. Cromos Pharma’s CRAs have undergone extensive training to ensure complete ICH GCP understanding. Their Selection is based on both level of experience and professional capabilities.

Services:

• Project Management
• Clinical Development Planning
• Feasibility Studies
• Investigator Selection and Management
• Site Management
• Clinical Monitoring
• Center Termination
• Data Management
• Regulatory Affairs

Investigator Selection and Management

Careful site selection is a key to successful patient recruitment.

Cromos Pharma has excellent personal contacts with a number of opinion leaders and scientific experts who are willing to act as principal investigators and members of the scientific advisory boards for our clinical trials. Our well-established relationships in Russian and Eastern European medical communities give us direct access to key scientists and patients at the major medical centers.

Study Sites:

Most of our centers are the policymakers in Russia and Eastern Europe

Moscow Medical Academy
Russian State Medical University
Medical Center of RF President Affairs Management
Moscow Regional Scientific Research Institute
Institute of Pulmonology
Russian Medical Postgraduate Academy...

... and many other

Principal Investigators:

Opinion leaders in Russia, Ukraine and other Eastern European Countries

We maintain a proprietary database of investigators and then match them with a particular project based on their experience, and required patient population.

Cromos Pharma’s Training Programs for Investigators and Site Personnel

• Investigator meetings
• Individual ICH GCP training
• Site personnel training

Study Initiation
  The study initiation process includes:

• Development of study design
• Protocol writing and CRF (paper or electronic) design
• Translation of study documents into local languages
• Application and approval process
• Clinical trial insurance
• Shipping, distribution and storage of trial supplies including customs clearance

Clinical Monitoring

Our monitoring services include:

• Organization of investigator meetings
• Individual ICH GCP training for investigators
• On-site monitoring according to ICH GCP- and FDA-guidelines (pre-trial visits, site selection visits, site initiation visits, site trainings, monitoring visits, site termination visits)
• Electronic monitoringand query tools for on-line studies
• Source data verification
• Query management
• Intensive adverse event management
• Site management with continuous quality control
• Verification & collection of regulatory documents
• Regular reporting to the sponsor on study progress

Data Management Services

Cromos Pharma has expertise in data management technologies that help achieve global consistency and high quality through centralized design and control.

Cromos Pharma provides comprehensive data management servicesfor clinical trials:

• Development of data management strategy, plan, and customization of systems
• Design and development of CRF or e-CRF and CRF completion guidelines
• Development and programming of database and validated edit checks
• Customized site training
• Pre-entry review
• Double data entry and reconciliation
• Data verification, cleaning, and validation
• Query generation, resolution, and tracking
• Adverse event and concomitant medication coding
• Lab data importation
• Tracking and tabulation of protocol deviations
• Finalize and lock database
• Generation of final, validated data tables and reports 

Regulatory Affairs

Cromos Pharma adheres to the highest regulatory compliance standards. We have the ability and experience to handle submission and registration processes. We also support post-marketing obligations for pharmaceuticals, biotechnological medicinal products, and medical devices.

  Cromos Pharma’s regulatory affairs professionals provide the following trial services:

• Contacts and negotiations with regulatory authorities on your behalf
• Obtaining approvals from regulatory authorities and ethics committees (Cromos Pharma has 100% approval rate)
• Development/review of informed consent forms
• Clarification of regulatory requirements for Russia and certain countries of Eastern Europe
• Expert reports on quality, safety and efficacy
• Periodic Safety Update Reports (PSUR’s)
• Consultation regarding regulatory affairs of medical products and devices.