ikfe CRO Project Services

Consultancy

ikfe CRO provides competent support at any stage in your project.

Starting with a comprehensive initial consultancy meeting, we can support your project with its specific requirements from the early concept stage.

We are also happy to offer guidance for patent applications.

Our consultancy services include:

• Registration strategies
• Trial design
• Medical monitoring
• Publication strategies

Clinical Operations

Following on from our comprehensive consultancy and planning stages, your ikfe CRO team will provide support for specific project stages or your entire project.

Our clinical operations services include:

• Project and site management
• Site selection and feasibility check
• Investigator meetings
• Monitoring
• Supply of logistics

Data management

Expert biometric support can already be of great use to your project during the development of the study protocol.

As soon as your study protocol has been finalised, we we can create a database and start data processing and documentation.

Our data management services include:

• Database and CRF design
• Data capture – paper and electronic
• Data processing
• Query management
• Medical coding
• Statistics

Medical writing

The creation of a final report starts with the development of a study protocol and continues throughout the study documentation process up to the presentation of your trial results to the relevant authorities.

Our medical writing services include:

• Protocol writing
• IB preparationc
• Annual safety report
• Final and clinical expert reports
• Presentation and publishing of trial results at congresses and events

Regulatory affairs

• Submission and communication with authority for IRB/IEC approval
• Ad hoc safety reporting to relevant authorities and IRB/IEC

Study drug and medical device

• Import/export
• QP release
• Storage
• Labelling
• Logistics