IOSR-JBM   Volume-20 ~ Issue-9 ~ September-2018

Abstract: Banks are the life line of an economy as they play a key role in every economy. Banking in India has been through a long journey and the adoption of technology has brought a revolution in delivering banking and financial services. The Indian banking sector is passing through a critical phase and facing several challenges i.e deteriorating asset quality, constraints to adhere to Basel – 3 norms, low return on Assert, increasing trends, mandatory priority lending targets and risk – return trade off. Customer experience Management is the process that companies use to oversee and track all interactions with a customer during their relationship. Organizations are using CEM approach to anticipate customer needs and adopt the mind-set of the customer. The main aim of CEM is to optimize.........

Keywords: antecedents, banking sector, Customer experience, technology adoption

[1]. Dr.Tapas Kumar Parida(2018), Consolidation of Public Sector Bank-Will it serve any purpose?, The Indian Banker, Vol VI, No.1, August, 2018.
[2]. Yim. F., Hong-Kit, A.R., &Swaminathan. S, (2004), Customer Relationship Management: Its dimensions and effect on customer outcomes, Journal of Personal Selling and Sales Management, 24(4), 263 – 278.
[3]. Patwa, L.K. , &Patwa, K. K (2014), An analytical study of CRM Practices in Pubilc and Private Sector Banks in the State of Uttar Pradesh, Pacific Business Review International, 6(7), 60-69.
[4]. Berry, L. L., Carbone, L. P. and Haeckel, S.H. (2002), Managing the total customer experience, MIT Sloan Management Review, Vol. – 43, pp. 85-89.
[5]. Amir Nasermoadeli, KwekChoon Ling &FarshadMaghnati (2013), Evaluating the impact of Customer Experience on Purchase Intentions, International Journal of Business and Management, Vol. 8, No.6..

Abstract: Harmonization plays a key role in the modern world due to its impact on resourcing and budgeting. When submitting the dossier to regulatory agencies the requirements differ hence, there should be guidelines for companies to set the differences right. The drug development process submissions should be done in an integrated way to regulatory agencies although there are major differences between them. We should prioritize our requirement for easy implementation and determination. Since it causes double work to be done to regulatory agencies, we need to identify the gap and the requirement of implementation of the model and the need for standardization of regulations globally. Has time finally come to harmonize.........

Keywords: Harmonisation; CDISC; Regulatory harmonisation; Inter-organisational harmonisation model; One model; SDTM; ADaM; Controlled terminology; Scope; Implementation; Unified approach; Organisation benefit;

[1]. CDISC Clinical Data Interchange Standards Consortium https://www.cdisc.org/resources/global-regulatory-requirements
[2]. WHO, WHO Trial Registration Data Set http://www.who.int/ictrp/network/trds/en/
[3]. Protocol Representation: The Forgotten CDISC Model https://www.lexjansen.com/phuse/2016/cd/CD01.pdf
[4]. Protocol representation model https://www.cdisc.org/standards/foundational/protocol
[5]. CDISC annual report https://www.cdisc.org/system/files/all/CDISC_AR_2013C-Pages-web(1).pdfCDISC, Define-XML Specification Version 2.0, CDISC, 2013..

Abstract: Strategically planned implementation process across pharmaceutical organisations will ease the submission process. It results in increased efficiency, cost effectiveness, avoid unforeseen surprises and it reduces stress for the employees. Although it is a challenging task for implementation and execution of CDISC (Clinical Data Interchange Standard Consortium) compliant dataset, a well-planned submission process will lead to successful regulatory submissions. This avoids re-opening of data bases and helps in smoother submission processes. There is a need for technical expertise and effective cost management implementation process. CDISC vision is to enlighten patient care and safety through higher class of medical research. CDISC mission is to improve medical research and healthcare related areas. The major goal is traceability from collection of data till analysis. Food.......

Keywords: CDISC; Strategy; Implementation; Pharmacompanies; integration; Pharmaceuticalcompanies; Strategicimplementation.

[1]. "CDISC Foundational Standards" Clinical Data Interchange Standards Consortium March 2016. http://www.cdisc.org/foundation-standards.
[2]. FDA guidance for industry, Providing Regulatory Submissions in Electronic Format, Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf.
[3]. Study Data Tabulation Model (SDTM) (http://www.cdisc.org/standards/foundational/sdtm) http://www.cdisc.org/standards/foundational/define-xml)
[4]. FDA Study Data Standards Catalog (Version 4.5; Effective 2016-07-18) (http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM340684.xlsx)
[5]. Study Data Specifications. Current version: 1.4. August 1, 2007; Available via http://www.fda.gov/cder/regulatory/ersr/Studydata.pdf..