There are many business solution providers available to help you decide the design and wire diagram for your departments supporting the care and management of your clinical data but how do you choose the best solution provider? Start by looking for functional experts who have been operating for decades first, as they have experienced the high and lows of worldly economic challenges. They most likely have weathered through drastic changes to work ebb and flow before, so they should have contingency plans in place, and they will be ready to share their methodologies with customers.
First and foremost, your data requires experts to process the important, patient information into a standard format according to regulatory requirements for CDISC SDTM and ADaM and this requires filling positions with qualified and experienced life science, pharmaceutical industry programmers, data managers, and biostatisticians. You seek specialists who understand the specific function, rather than generalists and this calls for a Functional Service Provider (FSP).
People ask, “What is the difference between an FSP partner and a Clinical Research Organization?” The difference is between having expertise in a specific function and having a general understanding of the function as part of the whole. When it comes to the data management of your drug development program, you want the specialist model because the data is key to your success. If your specialist takes care of your data, the coordinating CRO’s job is going to be easier and the FSP approach offers a check and balance for you, the customer. The data FSP partner will ensure the data coming in from various solution providers is formatted properly, typically a very challenging job.
The FSP stays focused on the quality of data first and the CRO manages the overall timeline for the submission. The FSP will not allow the data to continue into the larger CRO picture until it is correct. It is like the passion of yin and yang. In Ancient Chinese philosophy, yin and yang is a concept of dualism, describing how seemingly opposite or contrary forces may actually be complementary, interconnected, and interdependent in the natural world, and how they may give rise to each other as they interrelate to one another.
Further, the data FSP partner will have access to the highest caliber of data resources your company will need. They will listen to your concerns and their solutions will lead you to a better, more forward-looking data operation for FY21 and beyond. Your best bet is to choose a Functional Service Provider (FSP), a business solution partner with very specific and focused expertise; one who understands and has worked in the specific function for decades and has kept pace with new technology and updated processes/methodologies that are proven to increase productivity while ensuring quality. Here are some of the benefits you will receive by choosing an experienced and seasoned data management FSP partner:
- Recruiting expertise and having long-term relationships with partnering agencies that give a priority to the best and most experienced data resources that bring efficiency, expertise, and quality to the function;
- Management expertise for handling day to day HR related responsibilities, and oversight of staffing so you can stay focused on the core business goals;
- Competitive Industry rates that represent fairness and value;
- Flexibility in designing organizational structures and level of effort based on need and technology in place. You, as the customer, should see first-hand how your partner is helping you navigate through the ebb and flow of the work especially through this challenging time; and
- Hourly rates applied to invoice for hours worked only.
The FSP partner option is quite fitting for FY21 with the pandemic still at the center of our everyday actions and decisions. The FSP flexible solution reduces risk while providing the expertise to develop a strong data function, something any serious company values so that their goals can be achieved.
Navitas Data Sciences is a Functional Service Provider of data resources and solutions.