White Papers

31. Finding New Solutions To A Current Unsustainable Model Of Clinical Trial Contracts & Budgets 9/30/2019

    In a clinical trial, so much depends on contract execution and budget development; when they are not appropriately managed, progress across other study start up areas comes to a halt. Valuable time is waster, which costs dearly. By implementing three successful approaches to a new way of conducting contracting and budgeting, sponsors and CROs can see a 37% faster site contract execution timeline.

32. Pediatric Clinical Research: Legislation Has Brought Progress, But More Is Needed 9/24/2019

    Overall, the progress made to date in pediatric clinical research is encouraging. However there is still room for progress to be made to enable more approved drugs to be brought to market that will help to control diseases in children, as well as offer potential cures. With collaboration of regulators and stakeholders on the rise they are also working to make more pediatric medicines available to children who need them.

33. Minimizing The Burden Of Clinical Trials On Children To Accelerate Pediatric Drug Development 9/24/2019

    One of the major challenges in conducting clinical trials in children, especially in rare and orphan diseases, is the limited availability of patients and reluctance of many parents and caregivers to enroll their child in a trial with an experimental therapy. Read more about the FDA and EMA concept of pediatric extrapolation to minimize the number of children that need to participate in a clinical trial.

34. Pharmacometrics: How PK/PD Modeling And Simulation Are Helping To Advance Pediatric Trials 9/24/2019

    Pediatric PK/PD modeling and simulation techniques are cornerstones of pediatric drug development. Read how PK/PD and other approaches to pharmacometrics address challenges of limited availability of suitable patients and parents’ inherent reluctance to expose children to unknowns.

35. Eight Must-Know Considerations About Rare, Dermatologic Trials For Children 9/24/2019

    Dermatology trials are somewhat unique, and even more so with children included in the trial. This white paper discusses some of the key considerations that should be taken into account when planning rare, dermatologic trials for children.

36. Clinical Trials & Travel Tribulations: Improving Access And Outcomes For Patients And Caregivers, Sites And Sponsors 9/19/2019

    In this paper, we dive into the logistical and financial challenges which increasingly impact all clinical trial stakeholders - from patients and sites, to sponsors and contract research organizations (CROs). Yet with proper planning and the right partners on board, travel arrangements and reimbursement programs can make the trial and patient experience more comfortable and successful for everyone.

37. Biologics - The Key To Next Generation Dermatology R&D? 9/17/2019

    Biologics present new treatment options for dermatology patients who haven’t seen positive results from traditional treatment methods, such as topicals, phototherapy or traditional drugs. This paper explores the evolution of biologics within the dermatology landscape, with an emphasis on clinical trial considerations for sponsor developing biologic agents.

38. Objectively Tracking Lesions In Dermatology Clinical Trials 9/17/2019

    There is an increasing need for objectivity in mapping and analyzing of lesions to create confidence in trial findings, reproducibility and translation to clinical practice for dermatology sponsors, regulators and clinicians. This paper examines evolving diagnostic practices coupled with advancing technology and their application to reduce subjectivity in dermatology clinical trials.

39. Commercialization Accelerator For Emerging Companies 9/17/2019

    For any life sciences company bringing its first product to market, the “commercialization to-do list” is long and punctuated by one critical strategic decision after another. This guide explores lessons learned from industry leaders facing the challenges of building commercial operations capabilities and how they avoid pitfalls.

40. A Framework For Successful Pain Measurement In Clinical Studies 8/28/2019

    Due to its complex nature, designing a study that effectively measures pain intensity and/or relief can be challenging. Health Decisions offers these considerations based on previous experience managing pain trials.