Company Overview

OPKO Biologics, a subsidiary of OPKO Health Inc., is a clinical-stage company developing next-generation, bio-better, long-acting versions of therapeutic proteins and peptide drugs, utilizing CTP and reversible PEGylation technologies.
OPKO Health, Inc. is a diversified healthcare company, focused on diagnostics and pharmaceuticals, that seeks to establish industry-leading positions in large, rapidly growing markets. OPKO health’s diagnostics business includes Bio-Reference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 420-person salesforce. It also has pharmaceutical and biologics businesses as well as production and distribution assets worldwide.

Challenges

OPKO Biologics has held 300 pre-clinical trials as of now, with a complex set of relations between the different trials. Oftentimes, a single biological process continues as two separate sub-processes which need to be attributed to the original one, with P/Ns that indicate the connection.
The amount of information that needs to be documented and managed is extremely large, so eventually, the company became overloaded with paperwork, folders and Excel spreadsheets containing product information.
The tools Excel had to offer for filtering the data wasn’t sufficient enough, and they couldn’t cross-reference data between the many different spreadsheets they had, costing them many hours manually searching and looking for specific data in the files.
Guy Wissotsky, USP Engineer at OPKO, describes the problem he had to face. “The biggest problem came up when we needed to find highly specific data, and had to rummage through piles of papers. In one case, we worked around the clock for 3-4 days under pressure of a deadline. It was awful. After this crisis, we knew we had to prevent the next one. First, we tried building a huge Excel file that would contain all the information, but that was insufficient. The file was humongous, and just configuring the top titles was excruciating. Excel doesn’t offer a lot of essentials, such as intersecting data by filters, which required programming. Also, the file was too complex for just any team member to use. After that we tried using Access, which was also unsuitable, as well as developing an in-house solution, but that required a lot of resources. Finally, we decided to move on to a truly professional solution”.

Solution

OPKO biologics used Data+’s Preclinical Drug Development Application to build a repository of trial results, in order to optimize their process and medical products.
Using the application, the OPKO team can document all the processes, results and trials. They can view the information in any way they choose, and pull out relevant data conveniently and without searching through piles of paperwork. The system helps the OPKO team easily and effectively monitor their biological processes and their inter-connections between preclinical trials.

OPKO users say –

• The system is very intuitive and offers all the functionalities you need. When I explained it to people, it didn’t take more than once.
• The system minimizes errors and prevents inconsistency. With hard copies, sometimes people would skip certain fields, whether intentionally or not. With Data+, that doesn’t happen. Also, you can always go back and correct any mistakes you made.
• In one of our departments, each process is different and requires different templates. With Data+, we can create our own templates independently, at any given time, which is a big advantage.
• One of Data+ biggest advantages is flexibility and simplicity. It doesn’t have hard-set limitations and is very easy to configure and customize. I can perform any action without too much effort.

About Data+

Data+ is a smart end-to-end solution that allows researchers to effectively record, manage and analyze clinical research data. A fully customizable platform which can be integrated with the organization’s systems and data, Data+ streamlines the research process and generates more value with the existing resources.
To get a demo of Data+, visit https://dataplus-research.com/contact/