By Ammie Z. Hill, MD, CMC, Medical Director, Drug Safety
MedDRA or the Medical Dictionary for Regulatory Activities is a tool that has remained to be a mainstay in classifying adverse event information associated with the use of biopharmaceuticals and medical devices. Ensuring consistency and accuracy of the assigned terms has allowed the biopharmaceutical industry and regulatory authorities to exchange and analyze safety data.
When I learned about the MedDRA coder certification examination I wondered if becoming a certified medical coder makes a difference. You become eligible to use the title of “CMC” (Certified MedDRA Coder) after your name; but, will it really matter?
Although a CMC certificate is not required by regulatory authorities, these two important reasons that I learned while preparing for the certification made it worth my time to take and pass the exam:
- MedDRA coding is not a simple task. There are general term selection principles as well as specific term selection points that the coder should take into consideration to ensure consistent and accurate term selection.
- Having the needed medical background or training is not enough. The coder should also receive MedDRA training. One needs to read and understand the “MedDRA Term Selection: Points to Consider” document. Attending the examination preparation webinar provided further clarification on the important steps to follow in obtaining the correct LLT (Lowest Level Term) for the verbatim description of the event provided by the investigator. It is important to always select the LLT that most accurately reflects the reported verbatim information. The degree of specificity for term selection can be challenging since the reported verbatim information can be ambiguous or vague and an exact match cannot be found in several instances.
Those interested in becoming a certified MedDRA coder can visit the CMC Web page. The CMC exam is online and based on the current version of MedDRA and the corresponding version of the “Term Selection: Points to Consider” document. The certification is valid for two years and is renewed after taking and passing the examination at the end of the two year period.
I look forward to renewing my certification in 2013.
What other reasons do you have for attaining a CMC certification?
By Donald F. McLean, MBA, Business & Contracts Associate
Choosing a Clinical Research Organization (CRO) is a daunting task. The number one concern of any pharmaceutical company is getting the product to market on time, the first time. Questions arise. Do you use multiple CROs that specialize in different areas or one CRO that does everything? Do you choose a small or large CRO? What attributes do you look for? Here are five attributes to help you narrow your search:
- Flexibility - Your CRO should be flexible. Being flexible is synonymous with niche CROs. Why? Because niche CROs are small, agile, and they can be seen as an extension to the internal team and less like an outsider. If quick response is needed, you’ll need a CRO that has a developed quick action process, such as Adaptive Parallel Processing (APP)®.
- Experience - Experience is a key factor. Senior leadership at the organization should be built from ex-pharmaceutical industry executives that have proven their success. Similarly, the members of the internal teams should have a certain amount of industry experience as well to better be able to service you, the client. You see this more often in niche CROs. Niche CROs won’t give you a B or C team, they give you the A team consistently, no matter what size company you are. And, when it comes time for that regulatory submission, a niche CRO will go above and beyond to show you that your submission is just as important as the rest.
- Speed and Accuracy - While drug development may be a lengthy process, when it comes to your CRO you want them to be fast and accurate. Along the lines of flexibility, a niche CRO can adjust speed much more easily than a large CRO due to less stringent and bureaucratic approaches. This is where an International Organization for Standardization (ISO) certification comes in. You’ll want to check to make sure the CRO you choose is ISO 9001 and ISO 27001 certified. These certifications are important to the quality and accuracy of your regulatory submission.
- Data Control - Your data needs to be clean and be kept clean. Also, ease of access is key. These two things allow you greater control over the project and the direction in which it is headed. A CRO should bring that experience that is necessary for the greatest clarity in your data, and that’s when you want the guaranteed A team that is brought forth in a niche CRO.
- Regulatory Requirements - When it comes time to take your submission to a regulatory authority, such as the FDA or EMEA, you’ll want a CRO who has an intimate knowledge with the agency. This expertise will help to avoid the common pharmaceutical submission hurdles and help your product get to market on schedule. Each of the four previous items relate to this category. Proven experience with pharmaceutical regulatory requirements is a must.
Flexibility, experience, speed and accuracy, data control, and knowledge of regulatory requirements are five key factors to consider when choosing your CRO. The combination of these qualities will assist them in acting as an internal extension of your team. Many small and large CROs have a good track record for certain reasons, but remember the large ones can be bulky and cumbersome while the small ones can be nimble and proactively focus on your needs. It takes time in choosing the right niche CRO, because out of the hundreds, you need to find the niche CRO that meets your needs. Once you choose your niche CRO you will notice the proactive approach, cost effectiveness, and greater control that comes with it. Control is always key when your credibility is on the line.
What other things do you look for in choosing the right CRO?