Streamline your PK/PD Data Programming & Support
It is a known challenge for companies to find and retain internal expert PK/PD data programming resources. Often data integration and manipulation requirements outpace in-house capacity for pharma companies. Certara’s best and most experienced data programming team is the solution for all your data programming challenges and needs. Our specialist data scientists have developed a standard program library, which shortens data assembly timelines. We are proud of our Data Programming numbers for the year 2020.
PK/PD プログラミング＆サポート
Our global team has enough programmers to tackle substantial tasks on short notice. We offer fast turnaround programming to support all phases of drug discovery and development in MIDD (Model–informed drug development). We save you time and money when you outsource your data programming work to us.
Our Services
- Population Pharmacokinetic and Pharmacodynamic (PK/PD) datasets
- Exposure-Response (ER Safety, ER Efficacy, etc.) datasets
- Simulation datasets
- NCA and ADNCA datasets
- PK CDISC standards (PC, PP, ADPC, and ADPP)
- PK TFLs for reporting
- Quality Control (QC) support
- E-submission regulatory support
- Expertise with SAS®, R® and other relevant software packages
なぜCertaraを利用するべきか？
Our mission is to anticipate and support the ever-evolving needs of clients throughout the data assembly & analysis lifecycle including submission support. Certara delivers industry-leading PK/PD Data Programming services that are high quality, cost-effective, and on time. Our precise Data Programming Road Map (process) bridges the gap between analysis plan and modeling. We transform your complex data (CDISC & non-CDISC) into a format that PK scientists can use for modeling and analysis to facilitate critical drug development decisions within your organization. Our flexible services enable you to contract with us on an individual resource need to scale up to a dedicated FSP (Full Service Partnership) level.
当社のチーム
Igor Rubets Associate Director
Sunil Mummidisetty Associate Director
Gerly van der Vleuten Associate Director, PK/PD Programming
Igor Rubets Associate Director
Sunil Mummidisetty Associate Director
Gerly van der Vleuten Associate Director, PK/PD Programming
Igor Rubets, PhD, a biostatistician with more than 25 years of experience in processing and analyzing results of clinical trials. Member of CDISC, ADaM, PK, NCA, and population PK teams.
Sunil Mummidisetty is a data programming lead specialized in PKPD analysis dataset development. He has over 15 years of experience in programming and reporting in Pharmaceutical & CRO environment. Prior to joining Certara, he worked as a Lead PKPD & SAS Programmer for Pfizer and CSL Behring.
Gerly van der Vleuten has a PhD in Biomedical Science and is located in The Netherlands.
She has more than 10 years of experience as PKPD data programmer and is coordinator of the European PKPD programming group.
Igor Rubets, PhD, a biostatistician with more than 25 years of experience in processing and analyzing results of clinical trials. Member of CDISC, ADaM, PK, NCA, and population PK teams.
Sunil Mummidisetty is a data programming lead specialized in PKPD analysis dataset development. He has over 15 years of experience in programming and reporting in Pharmaceutical & CRO environment. Prior to joining Certara, he worked as a Lead PKPD & SAS Programmer for Pfizer and CSL Behring.
Gerly van der Vleuten has a PhD in Biomedical Science and is located in The Netherlands.
She has more than 10 years of experience as PKPD data programmer and is coordinator of the European PKPD programming group.
