medical writing
Clinical Trial Support, Data Reviews, Claims, and Reference Sources
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clinical Trials
Clinical trials are the lifeblood of any pharmaceutical brand. Selecting enough candidates that may meet the eligibility criteria can be a challenge. Even when you have candidates, you must discuss the trial with them giving them enough information to provide informed consent before they even start the eligibility review.
We can help by providing tools to aid recruitment, inform and educate.
Clinical Trial Support
Recruiting participants for your clinical trial can be a challenge. Even when you have candidates, you must discuss the trial with them giving them enough information to provide informed consent before they even start the eligibility review.
Issue:
How can you provide information that’s easily understood by potential clinical trial participants?
Objective:
To provide clear communications about the process, procedures, and expectations for those considering entering a clinical trial. Enough so they can provide informed consent.
How we can help:
We take clinical trial protocols and turn them into communications that people can understand whether medically trained or not. We can create:
- Referral letters from lead clinicians
- Posters to increase awareness of a forthcoming trial, or one still recruiting
- Leaflets to explain what the trial is and whether it may be suitable for you
- Training pieces that nursing staff can use to help in one-to-one discussions with potential participants
- Guides to the trial, for participants and separately, for medical staff
Data Reviews, Claims, and Reference Sources:
Providing accurate, truthful and fully referenced claims is vital to engendering trust in the medicines we seek to promote.
As a body of clinical evidence for a brand develops, sorting through the data into approvable claims becomes more time consuming and challenging, especially for those new to the brand.
Issue:
How do you distil it down into bite-sized information that can form the heart of brand communication?
Objective:
To make it easier for local brand management teams to access the information they need to communicate consistent messages to their target audience.
How we can help:
We review clinical evidence and generate fully referenced claims documents to enable marketers to provide others in the company or their agency with an easy to digest summary of core data quickly and efficiently. Here are some examples:
- We can prepare a ‘White Claims List’. A single, updatable document with all claims and messages about a brand, categorised into efficacy by patient type, side-effects and adverse events, dosage, pharmacokinetics (and others as needed). Giving the claim, the Harvard/Vancouver reference notation for copy and paste without retyping, and the marked-up reference for local country copy approval system. Such documents can form the core reference source for brand communication.
- We can assimilate a set of diverse data and create a summary or review article that provides key learning points and is easy to digest for those in a hurry.