Running a business in the life sciences industry can be complex, and you might require a little outside help. Whether you’re working in the drug, biologic, biosimilar, or medical device space, it’s essential to get all the steps right if you’re looking to launch a product or service successfully.
Consulting services can be a beneficial tool that provide extra guidance and know-how in a complicated field. Working in the medical industry, especially where it’s concerned with widespread public health, means your business will be scrutinized and regulated by both the associated government agencies and the general public.
Of course, this level of oversight is for the people’s benefit, and companies should follow these guidelines closely. Life sciences consultants are at your service to help you navigate the many hurdles in front of your business.
Whether you’re new to the industry or you’ve spent years building your medical business, bringing on a life science consultant might be just what you need. Of course, it’s hard to tell whether or not it’s the right course of action.
Here are a few questions to ask yourself as a business owner to decide if you could benefit from a life science consultant.
1. How Much Experience do I Have in Life Sciences?
Is your business new to the market? Or is it established in the medical industry with extensive experience? Depending on who you are and what you do, life sciences consulting can drastically improve your position in the medical space.
New life sciences companies can learn a lot from good consulting. Some of the knowledge and expertise that’s taken industry leaders decades to learn can be communicated to you right off the bat, saving you time and stress. Life sciences consultants can help you create project plans and realistic timelines to ensure your operations go smoothly. Give yourself the resources to avoid stupid mistakes and hit the ground running with successful business ops.
Working with a life sciences consultant can benefit existing businesses as well. An experienced consultant can bring a fresh perspective to complicated operations and regulatory issues that may have troubled you in the past. Maybe you’re having trouble executing your clinical trial phases, or you’re trying to start up a new quality program initiative; a consultant will provide fresh advisory information to help you succeed.
2. Do I have the Budget for a Consultant?
Hiring a life sciences consultant can provide you with huge benefits and a pretty clear ROI on potential new ventures, but it will cost you accordingly. Before hiring a consultant, you should decide whether or not their services are within your budget. Companies like Treximo can work with you to make a consulting plan and pre-determine which level of services are within your reach.
3. Are we Dealing with Unique or Unfamiliar Government Restrictions?
Let’s get into the complexity of government restrictions. Regulatory affairs consulting can be significantly helpful when dealing with unfamiliar or complicated FDA regulations. Rather than navigate that landscape yourself and risk mistakes that either delay or destroy your entire project, a consultant can help you get it right the first time.
Treximo life sciences consulting is adept at handling CMC Development Services and creating custom strategies, guidance, and business execution within the medical industry.
Other complicated sets of regulations that medical device companies might work within are the EU MDR (European Union Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulations). Suppose your team doesn’t have the up-to-date knowledge and experience associated with these specific international regulatory requirements.
In that case, consultants can reduce your processing time and ensure the correct completion of your project.
4. How does this project compare to others I’ve done in the past?
A little guidance can go a long way. Anytime you’re dealing with a new project or taking on a special responsibility, it can’t hurt to work with an experienced professional.
If your company has conducted clinical operations but doesn’t have much experience with data analysis, your life sciences consultant can help. Statistical analysis can be a complicated process that requires a thorough understanding of your data collection processes and the clinical trial process itself.
Many of the regulations in place focus on statistical analysis measures, so it can’t hurt to bring in a professional consultant to do the job.
A poorly planned clinical trial can keep a life-changing drug from reaching the market. Each year, the American medical industry loses about $40 billion on drug development, primarily due to avoidable trial delays.
Proper planning and design can make a huge difference when it comes to releasing a new drug. An outside perspective can aid in clinical trial development, especially for those unfamiliar with the processes involved.
Complex Clinical Trials
Some clinical trials are more complex than others. Consultants can help you design complex studies with the necessary regulations in mind while minimizing the need for protocol amendments.
The Biotechnology Innovation Organization estimates that only about 10% of all drug trials make it past Phase I of development. Work with a consultant who understands the most common errors in the market so you can avoid them.
5. Am I Struggling with Speed, Quality, or Cost?
These factors come into play when working in pharmaceuticals, biotechnology, and even medical device development. Life sciences consulting can add data-backed value to your business.
Consultants target speed, quality, and cost to improve a business’s overall output and increase the likelihood of success on more projects.
A consultant can change the way you run your life sciences business for the better. Adding a new perspective to the way you do things, in addition to an extensive wealth of knowledge and experience in industry-specific fields, can help you determine a more accurate ROI for all of your projects.
Treximo can handle everything in the life sciences space, from study design and management to regulatory planning. If you’re interested in improving the way you do business, contact us for a free consultation.