Clinic Trial & Pharmaceutical Logistics in Russia and CIS countries

Risk management is the process of identifying, assessing and controlling threats to an organization's capital and earnings. These threats, or risks, could stem from a wide variety of sources, including financial uncertainty, legal liabilities, strategic management errors, accidents and natural disasters. IT security threats and data-related risks, and the risk management strategies to alleviate them, have become a top priority for our company.

We have implemented a risk management plan includes company processes for identifying and controlling threats to digital assets, customer's personally identifiable information and intellectual property.

Total Quality Management is a management framework based on the belief that an organization can build long-term success by having all its members, focus on quality improvement and, thus, delivering customer satisfaction.

Total Quality Management, requires organizations to plan the continuous improvement. It focuses on process improvements over the long term, rather than simply emphasizing short-term financial gains.

Total quality management is a system for a customer-focused organization that involves all employees in continual improvement. We are following the 8 principles of total quality management:

1. Customer-focused
   The customer ultimately determines the level of quality.
2. Total employee involvement
   All employees participate in working toward common goals.
3. Process-centered
4. Integrated system
   All processes are combined into business processes necessary to define and implement the strategy.
5. Strategic and systematic approach
   Formulation of a strategic plan that integrates quality as the main component.
6. Continuous improvement
   Continuous improvement forces the organization to be analytical and creative.
7. Factual decision-making
   Collect and analyze data in order to improve the accuracy of decision-making.
8. Communication
   Effective communications play a significant role in maintaining morale in the company.

Budget Allocation and Resource Planning

In order to improve strategic planning for long-term clinical trials and commercial success, companies must get the overall resource strategy right, structure a realistic budget, and be able to make decisions based on accurate forecasts.

Mastering outsourcing, partnerships, strategic alliances and project management of global clinical trials, allow our company to effectively manage resources and decision making to improve outcomes.

Companies in pharmaceutical, biotechnology, or medical devices industries are constantly pushing the boundary of innovation to develop new products. In addition, the industry is constantly being сhallenged to meet the rising standards of quality and to comply with rigorous regulatory requirements.

GxP (GMP, GCP, GDP) - Appropriate ... practices are a worldwide recognized system for ensuring the quality of medicines. The system of practices covers all stages of the life cycle of the drug.

Effective logistics with practice GxP ensures the uninterrupted conduct of clinical trials and the timely delivery of commercial drugs to patients.

Globe Medical takes a risk-based approach to compliance and quality management so company gain real-time visibility into the quality and document management process as its key performance metrics.

Collaborative planning and execution among clinical research, clinical operations, and supply-chain (logistics) are key elements in effectively managing an increasingly complex and global processes for clinical trials.

International clinical trials are essential to access larger pools of potential participants for studies and to ensure medicines can be approved in multiple regions. But managing globalised trials also leaves you facing increased logistical challenges. For example, many regulations in different markets are not clear and have been fluctuating in recent years.

Import and export regulations for transporting clinical products and equipment are also inconsistent, making it more difficult to plan and coordinate your clinical product supply chain.

Customise your logistics for each country: at the study planning stage, review the most efficient and cost-effective ways you can manage your clinical products chain for each individual country, to maintain your overall control of the study.

Know the importation rules for each country: find out the latest import/export licenses and regulation documents required for each country so you’re ready to comply with these throughout the trial.

Timely and accurate reporting is critically important in clinical trials.

At Globe-Medical, we know the value of information. That’s why we offer the best logistics and reporting capabilities available period. You stay in the know and in control.

We offer state-of-the-art logistical capabilities and reporting solutions that keep you in the know. Whether you want to know what you have in stock, when your next delivery is, or what you spent on a certain moment.