Whitepapers
Pharma white papers on contemporary issues, technologies, research, etc. are presented in this section to enable the readers with rich information and knowledge. This section provides white papers related to all the spheres of the pharma industry.
Navigating IDMP Compliance in the Pharmaceutical Industry
In an era of increasing regulatory demands the pharmaceutical industry faces the challenge of adhering to the Identification of Medicinal Products IDMP standards This whitepaper provides guidance to understanding and implementing IDMP compliance outlining the benefits and potential challenges and offering practical solutions We at AdEx Partners as Trusted Leaders in Business Transformation off...
RNA Therapeutics
An exploration of a rapidly growing field in the biotech industry with the potential to revolutionise the treatment of a wide range of diseases
How Clinical Trial Complexity Impacts End Users
Traditionally complexity in clinical trials is translated into increased operational challenges due to the presence of several IMPs populations trial sites multiple sponsors andor manufacturers and contract research organizations CROs
Phase-Appropriate Analytical Method Development
Drug development requires an average overall investment of USD billion and remains at high risk due to the huge attrition rate phase after phase The preclinical development phase and the phase clinical trial show the highest attrition rate due to toxicity or drug metabolism pharmacokinetic issues Mitigating the risk during a new drug candidate development program starting from the discove...
The New Normal: How COVID-19 Became the Catalyst for Change
When COVID disrupted life sciences solutions were needed in realtime As the pandemic grew so did the need to innovate Workers met the challenges They completed tasks fulfilled inspections and remained vigilant in fulfilling regulatory requirements This paper presents findings from a roundtable hosted by PharmaLex
Driving value creation through medical affairs in China
After more than three decades of fast economic growth China has entered the new normal stage marked by a moderate and stable domestic GDP growth rate Healthcare has been elevated to a national level agenda by the current leadership with the releasing of China Health
Launching Global Clinical Trials—best Practices For Efficient And Cost-effective Translations: A Lionsbridge White Paper
Summary The target market for conducting global clinical trials has changed significantly moving beyond pharmaceutical early adopters to the mainstream marketplace This shift has placed a heightened focus on the language challenges and complexity of running a global clinical trial More and more companies are moving toward
Pharmacopeia Requirements For Pure Steam And Final Rinse Verification Of Cip: A METTLER TOLEDO White Paper
Summary Validation of Pure Steam and the verification of the final aqueous rinse in a CIP process are defined by regulatory standards which change periodically and challenge system designers and owners to know the latest requirements This white paper contains an overview of current pharmacopeia requirements which will assist in the design and monitoring of comp
Effective Randomization Is Key To The Success Of A Trial: A Cenduit White Paper
Summary Randomized doubleblind clinical trials are the gold standard for adequate and wellcontrolled studies in modern times However prior to the late s randomization and blinding were not used in medicine and as result bias was common For example treatment bias was often observed as physicians would treat sicker patients with known controls while
Improving Strategic Supplier Discovery Through Technology: A Procurepharma White Paper
Summary This white paper will explore current trends related to procurement and sourcing is evolving role in the supplier discovery process and current practices for accessing supplier information It will explore the ability of new technology to enable procurement and sourcing professionals to reduce the time spent identifying qualified suppliers prior to initiating the RFP process Finally
