BIOMETRICS
AT ITS BEST
About Inference
Inference was founded to fill the need for quality Biostatistics and Data Management services in drug development. Their operations are anchored in deep experience in supporting a variety of development programs at the portfolio level, as well as expertise in support of individual studies. They translate trial objectives to testable hypotheses, develop optimal study designs, and formulate best analytical strategies for reporting the data. Their understanding of the science and the ever-changing regulatory expectations worldwide is reflected in how they collect clinical data, maintain integrity of the trial, and finally how they make statistical inference. After all, accurate clinical conclusions must rest on flawless execution and reporting of the data.
Schedule a meeting to learn more about how Inference can empower your trial analytics!
Inference Services
01
BIOSTATISTICS
At the core they are a statistical company. Their expertise is in statistics, as it is applied to all phases of drug development. They do it deliberately, efficiently, and with passion. Our expertise includes preparation on statistical designs, statistical analysis plans, and statistical support for data monitoring.
02
DATA MANAGEMENT
Good inference can only be based on good data, and collecting good data has to be planned properly and executed flawlessly. They provide end-to-end clinical data management services, including database development and deployment, data migration, and data analytics.
03
STATISTICAL PROGRAMMING
Reporting of data to regulatory agencies requires programming of standardized datasets, meaningful and validated outputs and thorough documentation for the reviewers. This includes customized CDISC solutions, programming SDTM and ADaM datasets from raw data and providing centralized data storage and a metadata repository.
04
PHARMACOKINETICS
Much of drug development rests on questions about dosing, safety, drug interaction, bridging of formulations and populations, and characterizing the PK profile of the molecule and its metabolites.
05
MEDICAL WRITING
Inference's medical writers have years of experience in preparing ICH-compliant study documents from protocol to CSRs to integrated documents for summary.
06
STAFF AUGMENTATION
Inference offers a Functional Service Provider (FSP) model to sponsors to augment the sponsor's team on both a short and long-term basis. Their model is flexible, cost-effective and is managed by a well-defined governance structure.
Get your time back and let us find the solutions you need!
GLSA’s Global Network of solutions incorporates a variety of CROs and specialty vendors to support the specific needs of your clinical trial. Our network includes full-service CROs, biometrics, site selection, patient recruitment and retention, clinical supply chain management, and more. GLSA pre-qualifies all members of our network so you can be comfortable working with quality service providers.
We connect Sponsors with the CRO that has the right experience, culture, and capabilities to execute their research protocol. We leverage our extensive experience and harness our key relationships to work for CROs. We can fill any gaps you need to support your client’s trials. GLSA takes the guesswork out of vendor selection with our industry experts and experience.
What are your challenges? Contact GLSA to learn more about how we can help you accelerate your speed to market.