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CRO Medical and Regulatory Consulting Considerations for a Clinical research Organization



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Good Clinical Practice (GCP) requires that a Clinical Research Organization should be inspection ready at any time point in the year.

Data integrity has always been a key focus from a patient safety point of view, however with regulatory agencies all working in their own systems and procedures, with their own laws, regulations, and guidelines, CRO medical and regulatory consulting is taking on a global context.

Looking at new drug applications in several pivotal early-phase studies brings challenges for the inspecting agencies.

Agencies that have been performing inspections for several years have their own sets of regulations. For instance, some may focus mainly on processes and procedures behind the performance of studies.

The objective is to ensure that data are collected correctly in the view of the subject’s protection and safety.

Reports provided at the conclusion of an inspection have a grading for each of the findings and whether or not any action is needed from the sponsors.

Investigator Oversight

Delegation by investigators is a topic that has raised a lot of interest for many years. The quality behind the data is the responsibility of the investigator and root cause analysis identifies non-compliances and how to handle them.  For example, it also looks into technology aspects as working more and more on the electronic level and the validity of this data.

A lot of the oversight is handed over from the sponsor to a CRO and working in that situation can be a challenge, mainly moving from the local and per country way of thinking in a more centralized way.

For instance, in Europe making that there is only one trial application for a multi-site approach in Europe same for sister reporting everything going through a central registry database in Europe and exactly that database is one of the defining factors on when the regulation will become effective because they have only just started to develop that database.

A clinical research organization does not want to be in a situation where the FDA knocks on the door unexpectedly and they’re not ready to receive them and have to clean up the mess two days before the inspection. This is where a CRO medical and regulatory consulting company can be of help.

Inspection Readiness

Implementing the whole inspection readiness thinking as a state of mind is necessary every single day of the year to avoid the last-minute preparation activities.

Creating a culture of compliance in the company is necessary not only for the nurse on the floor, the management level, for the biometrics person or the monitor. A culture of compliance for the whole organization needs to be looked into, taking into account Quality Management and the systems behind quality control from day to day. Implementing this is best left to the expertise of CRO medical and regulatory consulting companies.

Organizations are focusing on internal audits or site audits and what also comes into the picture is the training of people who are going to be confronted with an inspection. They need to know how to present and how to express themselves.

They also need to know what the regulatory inspector is using as tips and as tricks on getting answers to their questions.

Continuous quality improvements in how data is being collected at the site and whether the data is collected to conform to the protocol are important factors. Consideration also has to be given to linking the way a CRO is working to a risk assessment approach and how to ensure that management is engaging in the whole process.

Implementing Quality Control Spot Checks

Spot checks within the CRO by an independent quality control person expert working separately from the operational activities and checking the quality at site level provides an objective view of how effectively quality control standards are maintained.

If  the clinical research organization can catch up on quality potential quality control issues at the site level before the monitor comes to look at the data we can at the site level still correct data before the monitoring is being performed thus handing over higher quality to the sponsors as well the spot-checked activity was based risk analysis

Spot checks can be done on two different levels. On the electronic front, data captured is available as a resource and can be used for the control mechanism and in a manual process, hands-on spot checks will look at performance issues relating to the roles and responsibilities of staff members across the board.

The results of spot checks carried out on a monthly basis could help identify trends and risks which need to be addressed. Generally, there are three different levels of trends. In a normal evaluation, if everything goes well many months in a row, evaluation at a lower extent can require fewer studies or a lower frequency of evaluation.

However, when something goes wrong and a potential issue is observed for several months, more controls on the same number of studies can be established.

More studies can be conducted on quality control processes and the results go into a reporting tool for assessment at monthly meetings with the management.

What is important is to involve management at different levels of the contract research organization, such as team leaders of the operational activities mainly for GCP actions to look at trends and define in what direction further quality control needs to go.

Quality standards are for everyone on the clinical research organization team, not only the nurses on the floor, but also lab technicians, investigators and others in the organization.

So whether or not a CRO is doing manual quality control or electronic quality control it is important to maintain a culture of compliance in the organization.

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