In Phase II-IV

PharmaNet offers all the clinical development services traditionally associated with conducting Phase II-IV programs. A key differentiating factor of PharmaNet is that in every program we conduct, PharmaNet provides an unrivaled combination of experienced project-management teams, senior management oversight, and an exclusive approach to building relationships with sponsors.

Biostatistics

The PharmaNet Biostatistics team is distinguished by a large library of published papers.

 

Laster, LL, Johnson, MF and Kotler, ML. Non-inferiority trials: the 'at least as good as' criterion with dichotomous data. Statistics in Medicine 25:1115-1130, 2006
   
Yeh, E. A SAS database search engine gives everyone the power to know. PharmaSUG 2004 Conference and Proceedings, San Diego, May 23-26, 2004
   
Yeh, E. A SAS database search engine gives everyone the power to know. Conference and Proceedings of the 29th Annual Conference of the SAS Users Group International (SUGI 29), Montreal, May 9-12, 2004
   
Moyle, G, Sawyer, W, Law, M, Amin, J, and A Hill. Changes in hematologic parameters with, and efficacy of, thymidine analog-based, highly active antiretroviral therapy: a meta-analysis of six prospective, randomized, comparative studies. Clinical Therapeutics, 26:1, Jan 2004
   
  Sherman, AM, Shumaker, SA, Sharp, P, Reboussin, DM, Kancler, C, Walkup M, and D Herrington. No effect of HRT on health-related quality of life for post-menopausal women with heart disease. Minerva Ginecol, 55 (6): 511-7; Dec 2003
   
  Cella, D, Pulliam, J et al. Evaluation of pain associated with oral mucositis during the acute period after administration of high-dose chemotherapy. Cancer 2003; 98:406-412
   
Ringelberg, AS. The behind the scenes of extracting SAS® data sets from Oracle® Clinical. PharmaSUG 2003 Conference and Proceedings, Miami, May 4-7, 2003
   
Bairnsfather, S. Progress towards standardization of submissions with the electronic Common Technical Document and the evolving standardization of clinical data. PharmaSUG 2003 Conference and Proceedings, Miami, May 4-7, 2003
   
Verrill, D, Yeh, E, and S Kasichainula. Automating the creation of a single bookmarked PDF document from multiple SAS® ASCII and PostScript® output files. PharmaSUG 2003 Conference and Proceedings, Miami, May 4-7, 2003
   
Yeh, E, Kasichainula, S, and K Lanier. Automating the creation of Data Definition Tables (Define.pdf) using SAS® version 8.2. PharmaSUG 2003 Conference and Proceedings, Miami, May 4-7, 2003
   
  Becker, M. Executive Committee Member, PharmaSUG 2003 Conference, Miami, May 4-7, 2003
   
  Kasichainula, S. Section Chair, Biostatistics, PharmaSUG 2003 Conference, Miami, May 4-7, 2003
   
  Becker, M. Treasurer, PharmaSUG 2003 Conference, Miami, Florida, May 4-7, 2003
   
  Sherman, AM, Shumaker, SA, Kancler, C, Zheng, B, Reboussin, D, Legault, C, and D Herrington. Baseline health-related quality of life in postmenopausal women with coronary heart disease: the estrogen replacement and atherosclerosis trial. Journal of Women's Health, May 2003
   
  M Kurowski, T Sternfeldp, A Hill, C Mocklinghoff, and W Sawyer. Pharmacokinetic and tolerability profile of twice-daily saquinavir hard gelatin capsules (Invirase) and saquinavir soft gelatin (Fortovase) capsules boosted with ritonavir in healthy volunteers. HIV Medicine, 4:2, Apr 2003
   
  Bowalekar, SK. Statistical considerations in clinical research - regulatory perspective. Workshop on GCP Theory and Practice, conducted jointly by WHO and CDSCO (Central Drugs Standard and Control Organisation), Mumbai, India, Feb 13-15, 2003
   
Laster, LL and MF Johnson. Non-inferiority trials: the 'at least as good as' criterion. Statistics in Medicine, 22:187-200, Jan 2003
   
  Goldston, D, Reboussin, B, Kancler, C, Daniel, S, Frazier, P, Harris, A, Kelley, A, and D Reboussin. Rates and predictors of aftercare services among formerly hospitalized adolescents: a prospective naturalistic study. Journal of the American Academy of Child and Adolescent Psychiatry, Jan 2003
   
  Mann, J. Accredited SAS Institute trainer (pending) and co-developer, SAS System essentials for pharmaceutical users. 3-day course, in conjunction with SAS Institute, 2002-2003
   
  Hirshorn, W and M Jarvis. NUR 595: Concepts of pharmaceutical development and operations. 3-credit graduate course, post-masters certificate program, La Salle U, 2002
   
  Becker, M, Kasichainula, S, and J Moore. Pitfalls and successes of automating in-text tables for a clinical study report: a case study. PharmaSUG 2002 Conference and Proceedings, Salt Lake City, May 5-8, 2002
   
Becker, M, and K Moses. Data definition tables - definition and automation. PharmaSUG 2002 Conference and Proceedings, Salt Lake City, May 5-8, 2002
   
  Becker, M. Executive Committee Member, PharmaSUG 2002 Conference, Salt Lake City, May 5-8, 2002
   
  Kasichainula, S. Section Chair, Biostatistics, PharmaSUG 2002 Conference, Salt Lake City, May 5-8, 2002
   
  Becker, M. Section Chair, Tutorials, PharmaSUG 2002 Conference, Salt Lake City, May 5-8, 2002
PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390