Mastering Good Clinical Practice (GCP): Oximio’s Guidelines to Setting up Successful Clinical Trials

Setting up a clinical trial requires meticulous planning, particularly when it comes to the intricate logistics involved in the execution of that trial. Encompassing multiple aspects, the steps in clinical trial logistics cover a multitude of challenges. These can range from the enrolment and retention of patients, procuring the necessary medicines and instrumentation, meeting regulatory requirements, transport, storage and labelling. Additionally, what happens at the end of a trial? Post-trial procedures such as return and destruction of unused medicines must be accurately accounted for.

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) stands as a worldwide benchmark for ethical and scientific quality standards for the planning, execution, delivery and reporting of clinical trials. It adheres to the principles laid out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and imposes stringent standards to ensure that clinical studies observe ethical practices.

There are strict guidelines in place to ensure that the correct documentation is kept for the clinical protocol. This encompasses all record keeping, training and facilities and extends to computers and software. Quality assurance and inspections are carried out to ensure that these standards are met. GCP guidelines are set out to ensure that all research is scientifically accurate and that all aspects of the trial are correctly documented.  

In addition, GCP directives are put in place to protect the human rights of those participating in a clinical study and ensure the efficacy and safety of the compound being developed. The recommendations set out the best practices on the conduct of trials, defines the roles and duties of institutional review boards, investigators, sponsors and monitors.

At Oximio we have been providing end-to-end clinical trial services for over 18 years. Following good clinical practice, we have outlined a summary overview of the key steps in a clinical trial to ensure the smooth running of logistics.

Project Set-up

• Clinical Trial Coverage
  
  • Ensuring comprehensive clinical trial coverage is crucial for successful trial implementation. When selecting a region for a clinical trial the evaluation of regulatory frameworks, patient demographics, healthcare infrastructure and logistical factors all need to be taken into consideration.
• Supply Chain Planning
  • Careful and meticulous supply chain planning is essential to meet timely and reliable delivery of investigational drugs and essential materials. This will help ensure seamless execution of the trial, data integrity, and patient safety.
• Risk Assessment
  • Guaranteeing the quality of any clinical trial involves an assessment of potential risks to both the trial participants and the reliability of the trial results. By identifying these risks and implementing appropriate mitigation strategies and backup plans, the overall benefit and integrity of the clinical trial can be significantly improved. Risks could include patient retention, travel disruption, insufficient budgeting, staff turnover to name a few.
• Regulatory Compliance
  • Prior to setting up a clinical trial, it is essential to attain regulatory approval from the relevant authorities. This could be at a local or international level. Regulations will vary from country to country and may involve dealing with local Ministries of Health, Customs Authorities, Qualified Person (QP)/Responsible Person (RP)/Pharmacists.
• Study Documentation
  • In line with GCP, it is a requirement that all clinical trial information is accurately recorded to ensure traceability, verification, and analysis. Examples of such documents include drug classifications, labelling for storage and transportation, Investigational Medicinal Product Dossier (IMPD). This may involve liaising with suppliers, Clinical Research Organisations (CROs) and third parties.
• Budgeting
  • Careful budgeting means understanding the full scope of work. Costs will vary depending on the type of study, where it is to be conducted, and size. Costs to be factored include start-up fees, site, transportation, storage, labelling, personnel, patient care requirements and data collection.

Clinical Trial Ongoing Project Management

• Import/Export Licence Application
  • The need for import or export licences can arise depending on the international nature of a trial and the movement of investigational medicinal products (IMPs) and other trial-related matters across country borders. These can vary across countries and can depend on factors such as the type of product, e.g., human blood, tissue samples, medicines, the country of destination and the phase of the clinical trial.
• Customs Clearance/Importer of Records (IOR) Brokerage
  • When importing goods into a country where a business has no representation, the services of an IOR will be required to ensure that goods comply with the customs and regulations of that country. Without proper documentation, shipments may be delayed, detained or even refused entry by customs officials.
• Transport & Storage
  • Reliable transport and temperature control storage may be necessary for the movement of medicines and sample materials. Checks need to be made to ensure that medicines and sample materials are kept at the appropriate temperature during transportation and on arrival at their destination. These may require specialist temperature control solutions ranging from ambient to ultra-low temperature and in some cases, cryogenic storage.

Customs bonded warehouses should also be considered for the storage of goods as they can provide certain advantages, such as the deferment of customs duties and taxes until the goods are released from the warehouse. Cost benefits resulting from the deferment of customs duties and taxes, until the goods are ready for shipping can help sponsors manage budgets. 

• Sourcing for Clinical Trials
  • Reliable access to comparator drugs is a key part of any clinical trial. In addition to navigating regulatory, operational and logistic requirements, it is essential to acquire sufficient stocks for the duration of the trial and negotiate the most favourable price. This can also apply to ancillary products which may be required for the trial.
• Patient Services
  • The well-being of the patient is at the heart of any clinical trial and ensuring that they receive the right drug at the right time is vital. Subject to location, some factors to be considered when organising a trial include transportation, accommodation, and meals. If the patient is unable to travel, then a direct-to-patient solution will have to be provided.In some cases, the availability of unregistered medicinal products outside of clinical trials can be crucial for various reasons. In such instances, seriously ill patients may be granted regulatory approvals to receive treatment with these drugs. This supply of medicinal products is commonly known as post-trial access or compassionate use.

Concluding a Clinical Trial

• Final Product Inventory
  • At the end of the study trial, all products need to be appropriately reconciled, documented, and submitted for reporting. Typically, clinical research companies consider a study trial closed once the study report is finalised, and the database is securely locked.
• Returns, Accountability, Destruction
  • Unwanted, surplus medicines or ancillary products will have to be collected from the investigational site. The study equipment will have to be returned to the supplier. Medicines will also have to be disposed of according the relevant regulations and a certificate of destruction issued.

Oximio’s Clinical Trial Logistics Services

If you are looking for support with your clinical research trial, Oximio’s start to finish project management services and end-to-end clinical trial logistics, can cover all areas featured in our guide. To find out how we can support you with your clinical trial please contact us.