This includes, but is not limited to:

• Providing the structure (e.g., filing, naming conventions, training on nomenclature, glossary, and definitions, etc.).
• Clarifying with you the short- and long-term goals to enable better prioritization of resources.
• Writing of the first set of Standard Operating Procedures (SOPs) together with your Quality Management responsible to enable the first clinical trial to start on time.
• Preparing (annotated) templates for plans, manuals, trackers, and checklists – tailored exactly to your needs - to ensure your Clinical Operations group can work according to the highest quality standards.
• Preparing salary bandwidths, employee development plans, and position descriptions tailored exactly to your Clinical Operations group.
• Supporting you preparing the job advertisements and performing job interviews to produce a short-list from which you can select the right candidate for your company.
• Perform the search and evaluation for the best Contract Research Organization (CRO) to manage your clinical trial(s) according to your needs and budget.

Back

• Setting up the necessary SOPs to allow you to prepare, submit to regulatory authorities/ethics committees and manage your clinical trial(s).
• Review your existing SOPs to simplify procedures, improve and/or to accelerate the execution of your clinical trials.
• Along with your Quality Management responsible: providing support with the 2-yearly review to ensure your SOPs are up-to-date and according to the latest regulations.

Back

Clinical Trials should be scientifically sound, and described in a clear, detailed protocol (ICH GCP 2.5)

We are able to review your protocol(s) (e.g., prior to submission to authorities and ethics committees) with a special focus on ‘operational feasibility’ and provide detailed feedback with potential solutions.

Most companies ensure their protocol(s) are “scientifically sound” although often are not fully aware if they are operationally feasible.

This is key and ensures:

• the clinical trial will be conducted at the highest quality standards
• the site personnel will enroll suitable trial participants into your clinical trial
• there are fewer protocol deviations
• fewer protocol amendments are needed

➔ hence faster trial timelines, better quality, and lower costs.

You have the feeling your clinical trial is too slow?
It is not recruiting as fast as you would expect?

Following a full review of your trial documents, SOPs, and interviewing your team, unnecessary, cumbersome, or missing processes, toxic team behavior or meeting culture may be identified. With 20 years of experience in clinical trial management in diverse companies we can work together and develop long-lasting solutions.

Back

• Training your team on what to expect.
• Ensuring your team is ready and has all the necessary plans, manuals, trackers, and checklists in place.
• Helping your team to prepare the Corrective and Preventive Action (CAPA) plan after the inspection/audit and implement the CAPAs on time.

Back

• Leadership skills are the key to success and successful outcomes. We can help you learn how to empower your team and listen to their opinions without judgement to achieve your own goals.

• Leadership skills are not present at birth – but they can be learned with practice, dedication, and courage to embrace change.
• Leading a team is difficult – but there are ways to improve. We can support you to reach that next level.

Back

• Maternity coverage, short-term sickness leave? We can manage your clinical trial to cover such eventualities.

Back