Our specialized biostatistics and data management consulting services empower your organization to elevate its use of cutting-edge data.
Your needs are variable—sometimes you need a full-time resource, while other times you need flexible support. Whether you’re looking for on-demand short- or long-term support with individuals or teams, we can help.
We have depth of experience supporting clients to clarify goals, capabilities, timing, and gaps to present you with custom-crafted solutions. We leverage your internal team or outsourced providers and fill any gaps you may have.
Our biostatistical experts can provide strategic statistical input at the origination of a clinical program design, when planning key studies, or for interactions with regulatory agencies.
Our professionals are skilled at developing and executing your data management and statistical analysis plans, advising to ensure that your practices align with regulatory requirements.
With our extensive relationship-driven network and vendor management expertise, we work with you to select, manage, and/or close out your biometric vendors.
Our data management professionals are skilled at writing and reviewing code to ensure that it’s classified uniformly to maintain consistency and accuracy, using a clear and consistent framework.
Meet with a member of our team to find the right solutions for your life sciences company.
Talk to UsIndustry Insights
An emerging oncology company that relied heavily on outsourcing was moving into phase 3 of their first clinical program. They needed a plan and processes to develop and sustain proper oversight of key functional areas of their phase 3 program to prepare for a successful marketing submission and for future programs in their pipeline.
Industry Insights
A global pharmaceutical company had over 4 active INDs, with more than 20 clinical studies in phase 2 and phase 3 in oncology indications. Full-service CROs were utilized for each program, but after turnover at both the client company and the CROs, a decision was made to reassign the studies to a central, US based staff. This new study allocation lead to a lack of continuity, internally and externally, and the new team was having trouble getting up to speed on the clinical status of the programs. In parallel, a business decision was made to internalize data management operations.
Industry Insights
An emerging oncology and rare disease company with little internal infrastructure was experiencing rapid growth after demonstrating potential efficacy in phase 1 of their first oncology indication and was moving towards a fast-track submission. As the company worked to expand their internal infrastructure, they needed functional expertise across disciplines to ensure development success.
Industry Insights
By Julie Rosenberg, MD Safety in drug development is critical, and a Pharmacovigilance (PV) consultant can help you with this vital work. PV consulting has emerged as a crucial service for pharmaceutical and biotechnology companies, enabling them to navigate the complex regulatory landscape and mitigate risks associated with drug safety. Pharmacovigilance Consulting Ensures Drug Safety […]
