Project Management

Effective clinical trials project management is crucial for ensuring the successful and timely
completion of research studies. We understand that navigating the complexities of clinical trials can be challenging
and requires expert industry knowledge. With different procedures, regulations and language barriers across borders
to deal with, our team of experienced project managers will provide comprehensive support through every stage of the
process.

A clinical trial plan that’s right for you

Running a clinical trial requires stringent planning, organisation and co-ordination. Solid project
management is essential throughout to guarantee the smooth running of the trial at all times. Our clinical trial
project management service is designed to give you the best value for money, with flexible pricing. View the options
below and choose a plan that meets your budget.

Standard Plan

Tailored Plan

Set-up:

Regulatory compliance

Oximio QMS & Database

Strategies to meet regulatory compliance, investigation & email follow ups

Project design

Standard services design & forecast

Project solutions & planning, invoicing adjustments as per client request

Timeframe planning

Standard timeframes for services

Custom timeframes: expedited services set up internally

Internally training

Standard services & timelines

For tailored solution when needed

Study documentation

Set-up & collection

Communication with suppliers, CROs and third parties

Management:

Dedicated single point of contact

Dedicated meetings

Email support

Communication portal

Standard task management

Tailored project portal

Project time tracking

Reporting

Standard reporting

Manual or tailored reports that require additional resources involved tailored for
client needs

Quality vendor management

Standard activities

Out of standard Oximio activities

Study invoicing

Standard scheme

Adjusted as per client requirements (invoices / TL), client E-D-Selectronic system

Licenses:

Import license application

Consultation & Check list, communications with CROs, suppliers, calculations, expiry date tracking

Clearance support:

IoR, brokarage, VAT payments

Customs consultations

Consultation with CROs & suppliers for project

Initiating shipments

Initiating shipment requests with suppliers

Import support:

Invoices review, Green Light in 24h, communication with shippers, Brokers & couriers

Export support:

Export setup, customs clearance support, and shipment tracking

EXW basis: invoice preparation and pick up arrangement with client courier

Including transportation solutions for exporting shipment

Export approval

Closure:

Final inventory report at time of closure request

Reconciliation of materials at sites & returns

Communication with CRO and Sites

PM management of closure

Standard

Closure solutions

Final invoice

Client survey

Archiving of documents

extended per request

Clinical Return Plan

During the study start-up, we proactively develop a clinical return plan taking into consideration drug or country-specific challenges. Oximio’s project management team takes care of return management throughout the life of your study to avoid any backlog at investigational sites and performs drug reconciliation at the desired accountability level (either shipper, kit or pill).

We always consider site capacity and provide the necessary packaging materials (cardboard boxes, sharp-bins, bubble wrap) for returns handling.

By pooling the returns into bulks on the local, regional
levels we are removing the financial burden from the
sponsor and streamline trial closeout.

Bio-samples Management

As an established logistics provider with expertise dedicated to clinical trials, Oximio provides greater efficiency and control for the collection and return of your biological samples, while minimizing risks to safety.

With Oximio’s bio-sample management shipment service, you can expect:

• Quick and comprehensive administrative support in documentation management during the export of bio-samples
• Highly reliable temperature-controlled packaging
• Support for a range of temperature ranges, ambient, refrigerated, frozen and dry ice
• Door-to-door service, from site to the central lab
• Solutions overcoming road and infrastructure conditions
• Experts in the most efficient export routes
• Regulatory and customs clearance expertise
• Proven implementation of solutions during military conflict and other public emergencies

Bio-sample Logistics Workflow

1. The PI completes a collection request form (the form, as well as other export document templates, including a letter to customs and a proforma invoice, are prepared by Oximio in advance as part of the project setup)
2. Oximio collects the bio-samples from the site (including controlled packaging, temperature loggers and related materials – ambient; refrigerated frozen or Dry Ice, if needed)
3. Oximio performs export procedures
4. Oximio delivers to the central lab
5. Oximio provides P.O.D

Note: As the first organisation to resume operations in Ukraine since the start of the crisis, Oximio’s services offer a comprehensive solution that puts shipment integrity and staff safety first.

Bonded Warehouse Solutions for Clinical Trials

With customs bonded warehouses in Kenya, Georgia and Serbia, Oximio can support clinical trials across the globe. In addition to the customs privileges and cost-savings offered by our bonded warehouse solutions, clients can benefit from our additional warehousing and depot facilities across Africa, Europe and the Middle East. Our bonded and non-bonded warehouses provide:

• Regulatory Compliance:
  Oximio’s customs bonded and non-bonded warehouses adhere to strict rules and regulations set by customs authorities. They undergo regular inspections, have enhanced security measures, and employ trained teams to handle controlled substances and sensitive pharmaceutical products. These measures ensure compliance with applicable regulations, such as Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), thereby promoting product integrity and patient safety.
• Traceability and Record-Keeping:
  We maintain meticulous records and provide transparent documentation throughout the storage and distribution process. This ensures full traceability, allowing researchers and regulatory bodies to track and verify the movement of pharmaceuticals at each stage of a clinical trial. Comprehensive record-keeping also facilitates efficient inventory management, simplifies audits, and minimizes the risk of regulatory non-compliance.
• Efficient Logistics and Inventory Management:
  Our warehouses provide dedicated facilities for the handling, storage, and distribution of clinical products. Their specialised infrastructure, along with robust logistics capabilities, enables efficient management of inbound and outbound shipments, reducing the risk of product loss or delays.
• Temperature Control:
  Our custom bonded and non-bonded warehouses can offer specialist temperature control solutions such as ultra-low temperature freezers or cryogenic storage facilities assuring the quality of samples and medicines at all times.

Additional benefits:

• Enhanced Security and Compliance:
  Our facilities offer heightened security measures, including access control, video surveillance and alarm systems. These measures protect valuable investigational products and minimize the risk of theft, tampering, or unauthorised access. Moreover, strict compliance with regulations ensures that clinical trial supplies meet the required quality standards, safeguarding the integrity of research outcomes.
• Customs Bonded Warehouse
  • Cross Border Shipments
  • Bulk shipments to the warehouse with lower number of
    intercontinental flights
  • More efficient manageable sized supplies, re-supplies.
• Experienced Courier Partners’ Network
  • Reduced risk
  • Improved Supply Chain timelines
  • Local couriers with the lower shipment prices
• Attract more Clinical Trials
  • New technologies
  • Specific Temperature Control requirements
  • Cell and Gene Therapies

Courier Services

Our medical delivery couriers are exclusively dedicated to pharmaceutical transportation, ensuring utmost care and attention. To safeguard your valuable products, our delivery vehicles are equipped with temperature-controlled systems, monitored in real-time through GPS tracking.

Discover the flexibility and agility of our medical courier services, tailored to meet your specific requirements.