BiostatisticsTKL’s biostatisticians have earned a reputation for expert, responsive statistical support for clinical research trials. We are well known in the industry for our ability to produce statistical analysis plans compliant with International Conference on Harmonisation (ICH) guidelines and exceptional report tables and listings for clinical research reports. We are regularly called upon for our expert, reliable consultation in the full range of biostatistical issues. Our services include: Statistical Protocol Development – TKL biostatisticians work with clinical experts to prepare efficient study designs and statistical methods, targeted to achieve the research objectives, such as marketing-claim support, proof of concept, product registration, or other goals. In addition to drawing on our own extensive archives, we conduct research in study-design issues from published literature and from Freedom of Information Act sources. TKL has developed a network of expert consultants in numerous therapeutic areas and will also involve other experts as necessary to prepare a protocol that meets the highest, most current standards. Statistical Analysis Plans – TKL biostatisticians prepare ICH-compliant, complete and detailed statistical analysis plans for prospective determination of methodology, according to your and/or regulatory requirements. Preparation of Analysis and Data Presentations – TKL biostatisticians prepare a wide variety of materials to be included in integrated statistical and clinical reports following ICH guidelines. These materials include summary reports for support of marketing claims, product safety reports and other presentations. Presentation formats follow pre-defined templates and guidelines provided by you, or, if preferred, custom formats developed by TKL for the specific application and audience. Deliverable formats include Microsoft Word and PowerPoint, Adobe PDF and others. Regulatory Submissions – TKL biostatisticians regularly play key roles in submissions to the Food and Drug Administration (FDA), represent clients at regulatory guidance meetings from pre-investigational new drug (IND) through new drug application (NDA) submission and provide timely responses to reviewer’s requests for information. Our biostatisticians are experienced with mapping source data structures into formats of the Clinical Data Interchange Standards Consortium (CDISC), including the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). Statistical Consulting – TKL biostatisticians are available for reliable, expert consultation. |
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