Clinical Research Consulting

With close to 15 years of significant experience across various sponsor pharma companies (MNC & Indian) and contract research organizations (CROs such as IQVIA, ICON, Syngene, Syneos Health, etc.), we take pride in offering consulting services as either ‘end-to-end solutions’ or as ‘turn-key projects’ in the following aspects of clinical research / drug development:

  1. Regulatory submissions
  2. SOP writing / process improvement
  3. Protocol writing
  4. Site identification & selection
  5. Ethics committee submissions
  6. Clinical trial monitoring
  7. Clinical trial data management
  8. Statistical analysis
  9. Clinical study report writing

As a premium consulting organization, we have a network of 20+ high-quality clinical trial sites (with registered Ethics Committees), Investigators & SMOs across indications & diseases – in a plug & play / ready to be deployed state for clinical trials in various phases – including Phase II, Phase IIIa, Phase IIIb, late-phase trials and marketing studies

Clinical Project Management

Any project undertaken by an organization is only as good as its project manager. Clinical trials and studies are high-stake projects that involves huge costs, severe implications on timelines, directly impacting the organization’s R&D pipeline and future developmental plans. Due to the current lack of specialized project managers, who understand the importance of each clinical trial and its ulterior objectives, several pharma companies end up with delayed trials or huge cost over-runs. Deeksha-Consulting offers turn-key project management services as a specialized value addition. If your organization is looking for an experienced, proven & customer-centric clinical project manager who can run your clinical studies from any time-point (be it at the conceptualization phase, planning phase, maintenance, execution or just about to wrap-up), look no further. We clearly and explicitly understand the criticality of a project manager’s role – client-facing, stakeholder-management, communication-handling, providing timely project updates, finance-control, scope & schedule management and ensuring the smooth running of a project – and make sure that this critical role is always in line with the organization’s expectations

CRO Oversight

Globally, almost all pharma companies who outsource their clinical trials (irrespective of the size of the organization or the phase of the study) to Contract Research Organizations (CROs) have one common observation – “they are clueless as to what exactly is happening in the CRO / how is the CRO managing the study in reality”! Sponsors / pharma companies are only dependant on the various trackers that are often confusing or just end-up giving the same information without much value-addition. They are also crippled by the opaque communication channels amidst the maze of hierarchy deep-seated in CROs that any communication reaching the sponsor is sure to be stale – never the real-time information. Most Indian pharma companies may not have access to real-time databases / dashboards and will solely rely on the CRO’s updates, with very little confidence on the way their study is being run. CRO Oversight is a customized solution from Deeksha-Consulting, which brings in over a decade of experience in identifying the actuality of a clinical trial / study, by working alongside a CRO and providing critical & dedicated insights to the sponsors on the following:

  1. Subject Safety
  2. Data Reliability
  3. Schedule / Timelines
  4. Site Performance
  5. Quality of the trial – site visit reports, project management / PM support, SOP compliance
  6. Inter-departmental cohesiveness – how well are the different teams working with each other & do they really know the actual progress of the study, status of data review, deliverables, etc.

This is not all…

Visit the next page or click on the link below, to know about our auxiliary services – Training & OD Interventions and about our partnerships in Emerging Healthcare Technologies

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