Dear OASIS Technical Committee
As the Chairman of the TMF Reference Model Steering Committee and the co-Chair of the TMF Reference Model, I am writing to express my overall concern regarding the lack of alignment between the TMF Reference Model and the OASIS eTMF Standard.
The TMF Reference model was born out of a DIA special interest group in 2009, and has released versions 1.0, 1.1, 1.2 and 2.0 since then.
Number of individuals who have ever been on the TMF Reference Model = 454.
Number of currently members who are part of the ongoing communications= 364
Total number of companies represented since inception = 203
Companies represented listed below:
Aastrom | BD | Clinipace | Eli Lilly | Genzyme | ISI | Mcdougall Scientific | Paragon | QC2 | Shire | United Therapeutics | ||||
Abbott | Biogen Idec | Cognizant | EMA | Gilead | J & J | Medidata | Parexel | Quanticate | Sidley austin | URL Pharma | ||||
Abbvie | Bioventus | Consultant | EMC | | Janssen | Medimmune | Peter MacCallum Cancer Centre | Quintiles | Site - Australia | Veeva | ||||
Actelion | Bluebird | Cordis | EMD Serono | Glemser | | Medi-San | Pfizer | Rammell Consulting | Smith & Nephew (devices) | Vernalis | ||||
Adamas Consulting | Boehringer Ingelheim | Corementum | Endocyte | Global Clincial Conenctions | Kanglaite | MedNet Solutions | Pfizer | Regeneron | Solvay | Vertex | ||||
Advance research associates | | Covance | ePharma Solutions | Grunenthal | Kendle | Medtronics | Pharma Compliance | Registrat-MAPI | Spectrum | Wingspan | ||||
Akros Pharma | Cadence Pharmaceuticals | CRIX International - Quintiles | Epson & St Helliers NHS Trust | GSK | Kids Research Inst, NSW | Merck | Pharmacovigilant | Riverdale Ass | St Vincents, Melbourne | WIPRO | ||||
Alexion | Cambridge Cognition | CSC | eRegulatory Submission | GXPi | Kings College | MHRA | Pharmanet | Roche | Stem Cell Therapeutics | WWCT | ||||
Alkermes | CareLex | Cubist Pharmaceuticals | | Harrison Clinical Research | Kingston Consulting | Millenium | Pharmavigilant | Royal Marsden | Sterling Bio | Xoma | ||||
Allergan | CE3 | Cytrx | Ethicon / J&J | Helicon Therapeutics | Leo Pharma | Mission 3 | Phlexglobal | RQ2 | Sunovian | Xybion | ||||
Alnara | Celerion | Daiichi-Sankyo | FDA | Highpoint Solutions | Life Sciences Integration Partners | Mitsubishi | Photocure | Sacura | Syntax | Zymogenetics | ||||
Amgen | Celgene | Dainippon Sumitoma | Ferring | Human Genome Sciences | Eli Lilly | MMRX | Pierre Fabre | Safe Biopharma | Syntel | | ||||
Antisoma | Centocor | Datatrak | FHI 360 | i3 Research | Lorenz | Montrium | Point Consultancy | Sandoz | Takeda | | ||||
Aris Global | Cephalon | Debra Fadil Consulting | | ICON | Lundbeck | Novo-Nordisk | Pozen | Sanofi Aventis | Target Health | | ||||
Astellas | Cereve | DIA | Fibrogen | IDDI | Lung Rx | NaviGATE | PPD | Sanofi Pasteur | | | ||||
Astra Zeneca | Chiesi | Duke Clinical Research Institute | Forest | Imclone | Malinkrodt | Nektar | PRA | Santen | Teva | | ||||
Auxilium | Chiesi | DW Associates | Galderma | INC Research | MSD | Nextdocs | Premier Research | SBC Global | Tournier | | ||||
Bausch & Lomb | Chiltern | eClinical | GE Healthcare | Integrated Submission Strategies | Mapi | Novartis | Prostrakan (IIT) | Sepian | Transperfect | | ||||
Baxter | Circassia | Edetek | Genentech | Intercept | Mass General Hospital | Otsuka | Purdue | Servier | UCB | | ||||
Bayer | Clinilabs | Eisai | Genprobe | Intralinks | Mcdougall Scientific | Orion Pharma | QA Consultant | SGS | Uni of NSW | | ||||
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Based on the above, our level of expertise has to make us the TMF content experts.
Please can the content then be aligned to our expert input.
Kind regards
Karen
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