Phase 4 Individual Project 2 - Assignment Example

There was a keen and clear understanding that percolated through the organization: the company would focus on the discovery of ‘New Chemical Entities’ (or NCEs) and work towards the development of such molecules into viable drugs for sale in the market. The business goal of the company was to be a ‘market leader’ in the field of Drug discovery and research. The various laboratory instruments and equipment were chosen for procurement, based on the planned service capabilities of the company.

Our company had invested in top quality bio-safety cabinets, laminar airflow chambers, gel documentation systems, liquid chromatography systems, flow cytometers and incubators, to name a few. The laboratory set up involved bulk investment of capital and recruitment of scientific personnel to handle such precision instruments. Clients were given tours of the laboratory facility and audits were managed professionally. This brought a good reputation to the company and soon, the company won its first major client: one of the ‘Top 10 Pharma companies’ of the nation!

Pilot R&D studies were successfully conducted in the laboratory and the client was satisfied with the level of work and commitment. A few months in to the project from its first ever client, our company received a query to conduct ‘Clinical Trials’ on a particular drug that was discovered elsewhere. The management was keen to capitalize on such a wonderful opportunity that came along! ‘Clinical Research’ is indeed a dimension very different from ‘Drug Research and Development’; yet, it was lucrative since it promised good earnings in a much shorter duration.

Our company’s senior management consisted of a Managing Director (who was not from the Life Sciences background), a President (who was a figure head) and a Chief Operating Officer (who was specialized in consulting services). The Head of the R&D facility was consulted for expert advice on this new project. After a few rounds of internal discussion, the management decided to go ahead with bidding for this Clinical Research project. The client insisted on several rounds of negotiation to which our company acceded.

The final quote (which ultimately won the deal) was the lowest bid amongst all the local competitors. There were huge celebrations for winning the project and the existing employees were highly motivated and enthusiastic! The client expressed his urgency to begin the project with immediate effect. The Head of the R&D facility was now required to devote his time to the new project (though it meant a stark deviation from his original job responsibilities), owing to the project’s criticality. Resources were hastily recruited for the sole purpose of meeting the demands of this project.

New departments such ‘Clinical Operations’, ‘Clinical Data Management’ and ‘Regulatory Affairs’ were formed in order to cater to the sudden requirements of the ‘clinical research’ sector. The Human Resource Development team was under extreme pressure to recruit the right resources in a very short span of time. The then existing Senior Management arranged for the legal documentation in the absence of a dedicated ‘Business team’. The project timelines and the milestones for payment proposed by the Sponsor (client) were quickly accepted by our company, in a bid to initiate this major project.

A ‘Project Kick – Off meeting’ was arranged to formally commence the proceedings. A