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Our white papers are written by technical experts from many different fields, exploring and commentating on a range of complex subjects.

US Food Modernization Understanding the US Food Safety Modernization Act

Find out how to prepare for the FSMA with our white paper, including a step-by-step process guide.

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Mitigating the Risk of Mid-Air Collisions with Remotely Piloted Aircraft Systems (RPAS) Mitigating the Risk of Mid-Air Collisions with Remotely Piloted Aircraft Systems

We look at areas of improvement for both manned and unmanned flight operations to mitigate the risks of mid-air collisions between Remotely Piloted Aircraft Systems and commercial air traffic.

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SGS LSS Execute a Phase III Influenza Treatment Clinical Trial Utilizing Data and Key Performance Indicators to Successfully Execute a Phase III Influenza Treatment Clinical Trial

This paper will address how SGS utilized constant data tracking to mitigate the disease-specific challenges and successfully execute a Phase III clinical trial in influenza patients.

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Retailer Whitepaper cover Retailers: Understanding the Risks of Global Supply Chains

We present an investigation into supply chain complexity, considering how to reduce risk for retailers.

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H1N1 A Consideration of H1N1/09pdm and New Variant H3N2/13 as Agents for Human Challenge Trials

Within the field of influenza research, there is becoming an increasingly large place for Human or Viral Challenge Trials (HCT).

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Sputum Sputum Induction Method to Optimize Respiratory Patient Clinical Trials

This white paper will examine the use of sputum induction as a pharmacodynamic method to optimize respiratory patient clinical trials, including comparison to other methods, and a case study looking at asthma patients and healthy volunteers.

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Early Phase Clinical Trials Early Phase Clinical Trials in Patients with Hepatic or Renal Impairment

FDA and EMA guidances are intended to help companies evaluate the need for conducting PK studies in renal and hepatic impaired patients. Although many procedural recommendations exist, some key questions still need to be investigated case-by-case at the early stage of the project development.

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Transparency One Transparency-One: Supply Chain Visibility

We discuss the profound transformation taking place in food shopping and shopper behavior, and the challenges in monitoring the supply chain and measuring product compliance to drive consumer trust.

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Nucleic Acid Amplification Techniques Nucleic Acid Amplification Techniques (NAT) to Address Biosafety of Biological Therapies

Over the past 15 years, nucleic acid amplification techniques (NAT), also referred to as polymerase chain reaction (PCR), have played an increasingly important role in the characterization and evaluation of biosafety for human biological therapies.

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Mycoplasma Detection of Mycoplasma in Biopharmaceuticals, Vaccines, and Gene Cell Therapies

The detection of mycoplasma contamination is of utmost concern in bio-therapeutic and vaccine manufacturing. Now that streamlined assay validation procedures and GMP validated NAT tests are readily available, these methods can provide manufacturers with confidence in results required in production and batch release of products.

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