Clinical Trial Software & Compliance

Although many clinical trial sites wish to use technology, they are concerned about software compliance, particularly regarding 21 CFR Part 11 compliance. Using non-compliant technology can result in audits and tense interactions with the FDA and other regulatory authorities.  In order to obtain smoother and quicker approvals from the regulatory authorities, researches need to use […]

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digital clinical trials

The concept of a “digital clinical trial” means leveraging digital technology to improve patient and sponsor experience in handling clinical trials using digital tools to manage end-to-end clinical trial solutions. Digital clinical trials also improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation and has the potential to transform clinical trials […]

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Stem Cell Clinical Trials A Talking Point In Modern Medicine

In recent years, hundreds of clinical trial investigations were performed using stem cell to treat common and life-threatening conditions such as heart disease, Alzheimer’s and diabetes. But till now, the only stem cell-based treatment routinely reviewed and approved by the U.S. FDA is hematopoietic (or blood) stem cell transplantation. The efficacy and safety of stem […]

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How to choose a best eTMF software for your clinical trial

The efforts in managing and locating files are becoming tiresome for many clinical research organizations. Electronic Trial Master Files (eTMF) software is becoming necessary for managing clinical trial documentation replacing bulky files. If you are in search of an eTMF, then you need to be aware of many aspects and features you need to look […]

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Patient management and engagement software in clinical trials

The barriers between IT industries and the clinical research industry is quickly blurring. Now the software tools are sorting the most difficult management tasks in clinical trials. One such challenging task in clinical trials is patient management and engagement. The patient management software very well manages and executes all patient-related tasks effortlessly. While conducting clinical […]

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Patient focused drug development

Patient focused drug development is a pragmatic shift of drug development process incorporating patients participation right from first stage of drug development to the end. Patient centered drug development now has become the talking point in the clinical research industry. It helps to provide meaningful information from participants to researchers in order to preform research […]

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Virtual clinical trials

Virtual clinical trials (VCTs), also known as decentralized clinical trials or remote clinical trials, are conducted remotely by taking advantage of technologies and tools such as telemedicine, electronic consent forms, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), apps, wearables, digital biomarker collection, and online engagement platforms. Clinical development in drug development is a […]

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Protocol writing for your clinical trial

Clinical research is conducted according to an action plan known as a Clinical Trial PROTOCOL. Clinical investigation begins with the development of a clinical protocol and writing a research proposal is one of the most challenging and difficult in clinical trials. What is a protocol? The protocol is a document that describes the action plan […]

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