Technology Towards an Efficient Monitoring of Clinical Trials

Effecient Monitoring of Clinical Trials

Clinical Study and Technology are two such genres that are progressing at a rapid rate. The implementation of age old practices does not suffice in any of the scenarios. Clinical trials are common in pharmaceutical industries and they occupy a major part in the approval of a drug. If the process of clinical trials is backed by this evolving technology then the efficiency would be enhanced. Site visits are common in clinical trials but if it is backed by a technology driven study then the monitoring would be aggravated. TULA is one such AI driven tool that offers technological support in the process of Clinical trials performance, risk and compliance management. The major areas where TULA comes into play are:

Risk Identification

Every site is different from the other and hence the risks associated with them are also varied. The risk management strategies identified for one might not be applicable for the other. In this case technology can be of major help in identifying the possible risks associated with each of the sites through an estimated evaluation of their past records. This would enable the Clinical Research Associates (CRA) to put forward a unique risk management strategy for each site.

Action Alerts

Identification of abnormalities with every site visit might be quite time consuming. This slow process might even create a hindrance in the process of taking actions. The AI driven technologies are always active, thereby alerting the drug manufacturers as and when the defined metrics are crossed.

Risk Mitigation

When risk identification is solely being carried out by technology driven tools, the research associates can shift their complete concentration to the alleviation of the previously identified risks. The mitigation of risks in a timely manner will help in the completion of the clinical trial process faster.

Data Verification at Source

There are multiple sources that the data is drawn from; verifying the data after a considerable amount of time increases the workload. With the verification of the data at source through the utilization of technology would not only save time but even make the procedure smooth.

The utilization of technology might be new in the field of clinical trial monitoring but the benefits that they bring forth are immense. The use of such AI driven GRC tool like TULA will enable the organizations to save their hard earned time and work towards the reduction of the soaring costs. The complexity is increasing in the medical world and its only technology that can prevent it from taking a toll on the entire industry.


DDi to Exhibit VISTAAR at RAPS Regulatory CONVERGENCE 2019

September 21-24, 2019 | Philadelphia, USA

DDi will be featuring VISTAAR a cloud based Regulatory & Clinical Intelligence Platform that combines up to date regulatory content compiled by experts with advanced Reg Tech enabled by AI to deliver a unique regulatory intelligence solution that is both fast and cost-effective. Join us at the premier Regulatory event for the BioPharma and Medical Device community showcasing ideas, insights and technology among the pioneers of the regulatory Industry at RAPS Regulatory Convergence 2019.

Stop by and visit DDi at booth # TT 1 while at the event and learn how VISTAAR enables Bio Pharma and Medical Device companies to reduce regulatory complexity, ensure global regulatory compliance and speed up the time to market with its accurate, up to date and timely solutions for the industry needs.

Will you be at RAPS Regulatory Convergence 2019? Set up a time to meet with us!


Join DDi at DIA's Global Annual Meeting 2019

June 23 -27, 2019 | San Diego convention center in San Diego, CA

Join DDi at DIA's Global Annual Meeting (DIA 2019) from June 23-27, 2019 at San Diego convention center in San Diego, CA.

DDi is excited to once again exhibit at DIA 2019, the largest, longest-running event in the life sciences industry. From over 50 years, DIA have been hosting the global annual meet every year to bring professionals and innovators of pharmaceutical, biotechnology and medical device communities at one place.

Meet the DDi team at booth #1911 to get a demo of our AI and Automation Technology.

Join the fastest growing event. We’ll see you there!

 

Bulk/Non-Uniquely Number Kits in a Study

Clinical Studies

If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits.

This concept of Kits can be generously used to distribute and assign blinded Kits, like Open-label Rescue medication, Run in Kits and this is the best concept to handle ancillary supplies.

Clinical Trials that are completely unblinded, uses this concept for their full advantage.

Advantages

Avoid the processes followed for Discrete/Uniquely Numbered Kits – This will cut down the cost and timelines of a study, by passing the activities of discussions, generation, approvals, reviews and testing Kits Randomization Lists of both Dummy and Live Kits.

Fewer errors – The Kits Randomization list is always error-prone, just one wrong entry in the list may have meager to catastrophic effect on the study. So, SMEs always suggest taking this up only when this is completely necessary and use the advantages of Bulk kits.

Labels - Label creation is less tedious and simple when it is in Bulk, as there won’t be any need to share the kit number in advance.

Limitations

The Unique Device Identification (UDI) is a system that unambiguously identifies a medical device through its distribution and use within the healthcare supply chain. UDI is comprised of two parts i.e., Device identifier and Production identifier.

  • Cannot be used if all the Kits Types in a Study are blinded. (This can only be used if at least one kit type in a study is unblinded)
  • Individual Kit cannot be tracked
  • Individual Kit cannot be accounted

Labeling Digitization: Manage Data, not Documents

Labeling Digitization: Manage Data, not Documents

Maintaining Regulatory compliance at all times coupled with stringent timelines is an ongoing obligation. Creation and maintenance of labels or label documents is a continual process to any MAH since they have to collect and implement all the necessary changes in the label documents for regulatory approvals and compliance. Health authorities also communicate to the MAHs on updating information via notifications/amendment notification letters. In this regard, MAHs are responsible to collect product specific updated information from various sources and update core label information for each product on a time basis. Currently, this is done with a lot of manual processes that repetitive in nature and sometimes causing people burnout. Resorting to offshoring doesn't help much because of continuous oversight and attritions. Digitization of labels and utilizating technology solutions for end-to-end labeling operations using automation and some artificial intelligence (AI) will be the future.

Topics Covered in this Whitepaper Include:

  • How Core Data Sheet is Different from a Label
  • Label Data Points
  • Local label Content Management
  • Advantages with Digitization & Automation

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