Data Management & Clinical Trial Biostatistics – Standalone Backend Services

At Biopharma Services, we execute every step of a Phase 1 study from protocol development to regulatory submissions to recruitment to data management and statistical analysis to the final study report. But what if a Phase 2 or late phase study only requires backend services? What if the expertise of a PK scientist is needed? What if a Biostatistician can offer expert advice during protocol development? At BioPharma Services, any one of these standalone services, or a combination thereof, are offered by expert teams with decades of industry knowledge and experience. BioPharma Services offers Functional Service Provision (FSP) models to support your clinical research activities, emphasizing the role of clinical trial biostatistics.  

The Key Players; Statisticians, Pharmacokinetic Scientists,  Clinical Pharmacology Scientists and Data Managers.

Our Statisticians, Pharmacokinetic Scientists, and Clinical Pharmacology Scientists are involved from the early stages of study development from simple protocol design and review to more intricate discussions related to study populations, how assessments should be executed, to assessing qualification and randomization. BioPharma Services has previously, and currently, successfully provided functional services of our Pharmacokinetic  Scientists to our Sponsors. Here is an insight into our talented Data Management and Biostatistics team specializing in clinical trial biostatistics and clinical data management.

We strongly believe that our Data Managers play an integral role in collaborating very early on in the clinical trial process as well. Our Data Managers ensure that the protocol requirements and expectations from our Statisticians and Scientists are captured in our clinical databases. While adhering to the highest quality standards, it is our expert knowledge of intricate data management requirements that holds the key to a successful backend product. Our Data Management team was just recently recognized for the fastest time for building databases in the industry by our software service provider.

The right team makes all the difference when stand-alone, backend services are required for Clinical Data Management and Clinical Trial Biostatistics. Our Data Managers execute all clinical Data Management activities with utmost quality, but they also understand the requirements and expectations of the other functional groups with which they work so closely. Their expert guidance and support throughout the clinical trial process is crucial for a successful study.

Our Clinical Biostatisticians are vital to ensuring the key elements are identified for analysis and reporting. Whether we impart full Data Management and Clinical Trial Biostatistics services, or whether we provide a functional service by one of our team members, our Data Management and Biostatistics team is the right team for your stand-alone needs.

Clean, Accurate and Precise Data.

The right edit checks ensure quality data. A strong Data Manager includes the proper edit checks when managing the data, including complex multivariate, cross-form edit checks to ensure data consistency. Our Data Managers use a proactive approach when building databases and edit checks. A clinical database with little to no unforeseen issues results in quality data delivered faster. Data Management has evolved and our Data Management team bridges the knowledge of fundamental data management requirements and the ever-changing process improvements. Our Data Managers work with central laboratory vendors to meet the programming and regulatory standards required. 

Data Managers work with Clinical Operations to ensure the data required for statistical analysis is captured accurately. Every step of the clinical trial process is intricately intertwined, where even the smallest issue, if overlooked at the beginning of the process, can affect an even larger outcome later in the process. Our Data Managers bridge those processes for a seamless transition with every step of the trial. Not all Data Management Teams are built the same. Our Data Management team is built on decades of industry experience, from early to late phase clinical trials, with knowledge of various clinical platforms, and experience with multi-site studies.

Like our Data Managers, our Biostatisticians are involved early in the clinical trial process. Their expertise is invaluable when developing protocols, building databases, and authoring Statistical Analysis Plans. Their review of specific frontend deliverables verifies that nothing is overlooked when the data is ready for tabulation and analysis. 

Our Biostatisticians are actively involved with the pharmacy during qualification and randomization phases for studies with such design. Our Statistical Programming team continually adheres to regulatory standards and evolves regularly to maintain the most current requirements. Efficiencies are factored in to streamlined programming processes, which result in quicker turnaround times. Our Biostatistics and Programming team is also built on decades of industry knowledge and experience in various therapeutic areas. One of our experienced Biostatisticians may be the missing link in your study team.

Edit Checks Specifications (ECS) may just be one of the most indispensable study documents. It includes all the checks in place to verify the consistency and accuracy of the data. Without good, accurate data, all else is questionable. The only way to make certain the data is clean and accurate is to write strong edit checks, while maintaining a level of efficiency that prevents a Data Manager from closing out irrelevant discrepancies. Robust test case creation, to validate these edit checks, is also an art form. All possible scenarios must be tested, and this can only be done when a strong ECS is in place. A clinical Biostatistician also plays a vital role in ECS creation. But the Head of Data Management and Biostatistics at Biopharma Services will not reveal all her secrets about what makes her team invaluable.

It is not uncommon to see a Data Manager, Biostatistician and a Programmer communicate daily at BioPharma Services. It is also not uncommon for any of these three team members to actively participate in discussions with other functional groups and other vendors. BioPharma Services’ Data Management team has worked with external Statistics teams.

Why Choose BioPharma Services?

Our Programmers and Biostatisticians have worked with external Data Management teams. Our combined experience from single-site, early-stage clinical trials to multi-site, late phase clinical trials means that our services bring a wealth of knowledge to your team. We are committed to providing the best Clinical Trial Data Management and Clinical Trial Biostatistics services, whether it is through supporting our very own studies in our state-of-the-art Phase 1 clinic, or whether it be through supporting your clinical trial at multiple sites across the globe. 

Written by: Tania Pannunzio, Senior Director, Data Management and Biostatistics.