To help our visitors locate books which are relevant to their particular fields, we are in the process of re-building our online bookstore. Send us your your recommendations for inclusion. In the meantime, here are our reader-recommended books of the month. You may also search for additional titles in the ContractPharm Shop.
Go
Contracting in the UK - Outsourcing
is the fastest growing business activity in the UK. Go Contracting
in the UK details where the opportuntities are, the latest tax
and employment/labour law, how to set up in business, pricing,
marketing, law on temporary employment in the European Union,
handling diversity issues, pensions and IR35 legislation. Invaluable
to companies and contractors.
The
Selection and Use of Contract Research Organizations
- Choosing the right contract research organization (CRO)
can make the difference between getting a product to market
quickly and cost-effectively, and wasting valuable time and
money. The vast number of available CROs is increasing all
the time, and all of them make impressive claims. The Selection
and Use of Contract Research Organizations is your essential
guide to choosing the best provider. A history of the CRO
industry, audit checklists, and overviews of both the pharmaceutical
and medical device development processes create a comprehensive
overview of how to successfully select and manage a CRO for
your project. The book also discusses:"Guidance for selection,
protocol and contract development, project management and
monitoring of work"Common pitfalls and problems - how
to avoid them, and how to solve them if they do occur"How
to integrate efforts between groups to achieve the greatest
cost effectiveness while maintaining quality and timely production"Prototype
forms and templates for increasing coordination between multiple
working groups"A series of appendices covering hundreds
of prominent service providers worldwide, including contact
information"Operative regulations and lawsIn addition
to providing fundamental guidance on how to select and manage
a CRO in the product development process, this reference also
includes a set of eight databases that contain contact information
for prominent service providers in North America, Europe,
and Japan, and overviews of services they offer. It is a complete
resource for professionals in biotechnology, and pharmaceutical
and medical device development.
The
Jobbank Guide to Health Care Companies: Includes Hospitals,
Medical Centers, Clinical Labs, Pharmaceutical Manufacturers,
Biotechnology Firms, and More! - This book has contact
information on a range of medical and health care facilities,
including hospitals and medical clinics, office and clinics
of health practitioners, home health care, pharmaceutical
developing, manufacturing and marketing, biotechnology firms,
and medical and clinical labs
International Good Clinical Practice - The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.
Big
Pharma - Perhaps a bit of a journalistic approach, this
book ends up being a useful introduction to what the industry
should be doing to help it's image. Here's a sampler. Drug
companies pay celebrities to name-drop drugs on tv shows.
They fund 'patient organisations' to agitate governments and
regulators into allowing the latest and most expensive drugs
to be subscribed. They encourage the 'medicalisation' of what
we previously saw as minor health problems that never before
required treatment. They have been accused of going further,
with a ploy to 'create the disease and then market the drug
to cure it'. So-called female sexual dysfunction is an oft-quoted
example -- a catch-all disorder which can be diagnosed with
a range of symptoms from physical pain to just not being up
for it on a Saturday night. Welcome to Planet Pharma.
Outsourcing
Clinical Development: Strategies for Working with CROs and
Other Partners - The challenges facing large pharmaceutical
companies are stark: sales are slowing and research and development
costs are rising. There's an overwhelming need to reduce development
costs by as much as 30-40 per cent, whilst at the same time
significantly shortening development cycle times. Pharmaceutical
spend on outsourcing faces double-digit growth for the next
three to five years and yet, if outsourcing is to meet these
challenges, new models of collaborative and cooperative working
are needed now. "Outsourcing Clinical Development" offers
a guide to these new models and to future clinical outsourcing
strategy.
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