| The sensitivity of the processes implies that clinical | | | | Integrated planning of clinical trials across the |
| trials are long drawn processes, often lasting more | | | | organization enabling the best leverage of resources |
| than seven years from designing and planning of | | | | and their allocation as needed to teams |
| protocols to the final report. Every additional month | | | | Use of modular design, leveraging past work to |
| or year of delay implies millions of dollars in costs and | | | | create electronic case-report forms |
| lost revenues for pharmaceutical companies; not to | | | | Use of electronic data capture systems at the |
| mention the high risk of ensuring the sanctity of the | | | | origin point of data, i.e. by physicians |
| data from clinical trials. A streamlined and speedy | | | | Integrated data system that gives management |
| process for clinical trials impacts positively the | | | | an end-to-end view of trials, enabling better and |
| economics of companies, and often times | | | | quicker decision making |
| dramatically. | | | | An IT focus on the following areas in clinical trials can |
| Pharmaceutical companies, have, therefore always | | | | deliver immense value to pharmaceutical companies |
| been on the lookout to boost the productivity of | | | | and other stakeholders and build a more efficient |
| clinical trials. Some of these initiatives have included | | | | value chain: |
| adoption of new scientific approaches to refine | | | | Clinical data management: this could include databases |
| design of trials, globalization of trials for broader pools | | | | of investigators and their preferences to support |
| of patients and researchers and technological | | | | design of electronic forms, standard interface to |
| capabilities. Despite all these innovative approaches, | | | | integrate third party systems and automated data |
| end-to-end improvements in trial performances have | | | | checks to maintain data integrity acting as a bar code |
| been hard to achieve. Primary among the reasons | | | | for the clinical trials/ subjects |
| towards this have been: | | | | Safety data management to enable real-time |
| Lack of proper coordination between trials | | | | monitoring of trials towards early detection of |
| across the organization resulting in loss of | | | | adverse reactions |
| transparency | | | | Document management across all stakeholders |
| Inability to leverage historical work, specially | | | | with a single point to ensure version control and |
| pertaining to design of trials; instead of re-using and | | | | better information flow |
| learning from experience, teams continue to | | | | Clinical trials management: probably the area with |
| re-create protocol designs from scratch each time, | | | | the deepest potential for IT in activities like modular |
| resulting in a lot of wasted time and effort | | | | design and construction of consent and case report |
| Unreliability of EDC Study SETUP systems has | | | | forms, converting study design forms to electronic |
| meant numerous hours spent verifying and matching | | | | forms and databases with little manual work, |
| electronic data against actual physical data | | | | electronic invoicing, tracking drug supply flow, study |
| Incomplete performance measurement programs | | | | planning and budgeting, patient management etc |
| that fail to look at programs holistically and focus on | | | | Project & resource management: use of |
| specific parts only | | | | traditional and customized project management tools |
| As the search for productivity continues, | | | | including models to work with third party contractors, |
| organizations have increasingly found that re-doing | | | | track project progress etc |
| Clinical Informatics IT systems and increasing their | | | | Clinical trials data Management/Bioinformatic tools |
| effective usage in clinical trial programs can address a | | | | would help in constriction of the time period for the |
| lot of the above concerns and challenges. | | | | proceesing of various outcomes which includes |
| How IT helped clinical trial efforts | | | | accelerating the drug discovery process, the eCTD, |
| Leading pharmaceutical companies that have | | | | CTMS, Sharepoint, MOSS 2007, IVRS/IWRS for the |
| undertaken programs to re-align their IT systems | | | | randomization. |
| have reported as much as 10% reduction in trial | | | | In today's world, fragmented IT systems in most |
| durations. Companies have focused on improving | | | | pharmaceutical companies make data and trial |
| speed, quality and costs through a combination of | | | | management a difficult and challenging process with |
| activities: focusing on the right and accurate data, | | | | little real-time view of all relevant data on a trial. As |
| managing workflows and data transparency across | | | | the industry evolves and global clinical trials mature, |
| the activity chain. | | | | the role of IT will become increasingly important not |
| With costs skyrocketing, companies are turning to | | | | just for the pharmaceutical companies but for all |
| computerized systems and IT solutions to increase | | | | concerned in the process, including physicians, |
| productivity and maximize the efficiency of clinical | | | | statisticians, clinicians and third-party contractors. |
| trials. The adoption of such solutions will be integral in | | | | And to its highest potential all stakeholders in the |
| enhancing and transforming the data collection and | | | | clinical trial process need to be educated on the true |
| management aspects of a trial. | | | | features and benefits of modern clinical technologies |
| Another key activity that has immensely benefited | | | | and be willing to make the necessary mental and |
| from this wave of applying new technology has been | | | | cultural switch and support the adoption of such |
| in information and process design. Critical ways where | | | | solutions. |
| technology can and has begun to play a role include: | | | | |