White Papers

A selection of Kinapse insights and presentations is available here.  If you would like more information on any of these or any other insights please contact us.

Roadmap to a successful sourcing partnership with a CRO

Over the last decade, pharmaceutical and biotechnology companies have initiated a growing number of “strategic” sourcing partnerships with service providers, including Clinical Research Organisations (CROs).

Clinical Trial Management Information: A Guide to Implementation

To successfully evolve the Clinical Trial Management Information landscape, a critical, systematic and holistic approach to change is needed; an approach which incorporates an in-depth assessment of existing systems, future needs, potential solutions and change management, and above all, places the user at the centre.

Creating new value for biopharma

The biopharma industry to date has primarily relied on product-led value creation. The continually evolving healthcare ecosystem presents new value creation opportunities, and this paper explores the four strategic plays that we believe are the most promising for biopharma.

Quantifying impact in Market Access / HEOR

Strong, data-driven performance management through the measurement of Key Performance Indicators can help to demonstrate and improve the contribution of Market Access and HEOR functions to business critical goals.

Managing performance in patient centricity

Patient centricity is arguably the biggest driver of change in healthcare and the pharmaceutical industry at present, but it is often not clear what success looks like in this area. This paper proposes a framework for how pharmaceutical companies might assess performance in patient centricity moving forward.

Capitalising on Patient Insights

There is ongoing debate about the value of patient insights and their role in enabling companies to become more patient centric. This paper discusses what is really meant by the term ‘patient insights’, their potential value and how organisations can capitalise on them.

Sifting through the sourcing options

Outsourcing is on the increase, however selecting activities to entrust to an external supplier remains challenging. In this paper we present a methodology for making this decision.

Clinical operations comes of age

Over the years, we’ve had the privilege of helping companies improve their ability to successfully deliver clinical study programmes.

How regulatory affairs can be more patient centric

In this white paper, Kinapse investigate the use of patient-relevant endpoints in regulatory strategy, with views from both the EMA and FDA on how this can be done.

So how do you build a quality culture?

Kinapse attended and sponsored the 9th Quality & OPEX in Pharma & Biotech. If you missed our presentation read here why building a mature approach to Quality should be on your leadership agenda, and how industry leading pharma companies have transformed the way they think about Quality management.

Putting the patient first: How the life sciences industries might look in 2018

This paper discusses the challenges that the life sciences industries are facing, and the opportunities to address those in what is a dynamic new environment.

Non Promotional External Communication

This paper discusses the complexity of non-promotional scientific communication, its benefits and risks, and steps that companies can take to optimise their approach in this area.

Risk Based Approaches to Quality Management

This paper outlines some of the benefits of risk-based methods alongside our approach for establishing risk-based quality and compliance, advocating a wide-reaching scope in order to realise the greatest benefits.

Big Pharma R&D - thinking big, acting small

In order to thrive, we believe that Big Pharma needs to start thinking ‘big’ and acting ‘small’. Simply tweaking the old business model is no longer a viable strategy.

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