Hello Advait,
No soft copy transcripts are available. ReasearchBytes has the audio though.
Both ur queries are answered at the below link:
http://www.pharmaready.com/
Their eCTD suite is available as both Cloud and On-Premise model.
My perception is that most of their clients would be using the below model:
http://www.navitas.net/regulatory
In earlier posts, eCTD video was shared which shows there are 5 different modules which require different datasets based on clinical, non-clinical, bio-equivalence, etc..
As i understand, there is an initial evaluation phase wherein the client provides the unstructured/structured data from their existing systems for Navitas to plug into their platform, process and generate the compliant eCTD document.
Having said that, compared to innovators, Generic companies would prefer to buy the license/subscription to the platform given the high frequency of filings through DMF/ANDA.
Innovators while filing less frequently through IND's/NDA's will require more complex eCTD submissions given the amount of data involved throughout the clinical phases.
In CY2015, 799 commercial IND's were filed.
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/INDActivityReports/UCM485375.pdf
Having the eCTD platform alone is not enough. It needs to be backed by a solid base of SME and domain experts which Navitas has claimed to have.
Do go through the case studies at the pharmaready portal.
Also found couple of very good report on the CTMS players and competitiion:
https://www.mdsol.com/sites/default/files/Rave_CenterWatch_CROs-Juggle-Proprietary-Systems_20160301_Article.pdf
http://www.oracle.com/us/corporate/analystreports/ovum-odm-ctms-2241838.pdf
The last 2 slides show that more than Regulatory Compliance/Management, eClinical solutions such as EDC, CDMS, CTMS, eTMF, etc... are higher priorities.
Also, Navitas had mentioned in AR 2014 that they would like to create accelerators for Oracle CTMS (ClearTrial) similar to their Argus implementations. (Would need to follow up with mgmt)