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Combined Phase Trials combine all phases of a clinical trial. They go from one clinical trial phase to the next, seamlessly, saving money and time. They also reduce time and cost of conducting the study. (Also known as “Adaptive Trials”) Part of Combine Phase Trials is Master Clinical Protocol which is a new kind of clinical ...

A typical Clinical Trial Startup is usually delayed because of poor planning. The project manager has to hire a strong, professional clinical trial team. Then, processes such as SOPs and trial templates take time. If they fail to get these done, the clinical trial is delayed. The clinical trial project manager can have those systems in place ...

Project Managers often have to deal with an unproductive team. It is a challenge that the project manager has to troubleshoot. There are many possible reasons that the team does not perform well. The Project Manager needs to find the root cause and fix it, as soon as possible or the clinical trial is in danger ...

Clinical trials fail. That is a fact of life as a recent study (2015, Clinical Development Success Rates for Investigational Drugs) found that 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. Only half of all drugs are rejected during the process and fail due to a lack ...

Not all software is regulated by FDA. Some software may be regulated depending on what it does. You can take a lot of what we know about clinical trials and design them for the task. FDA does not regulate the software. They take a hands-off approach. They let companies design systems to work for them. It ...

Clinical Trial Feasibility Studies means finding the right investigators and patients then determining costs. It is done to evealuate how the test could fail then decide to proceed or not to proceed. The project manager and trial sponsor take the lead. They look at the records of investigators and see if they are able to do ...

Clinical Trial Project Managers are are not necessarily using the newest technologies in the marketplace. Microsoft Project is popular but it is twenty-years old. Inertia is the main reason for not switching to the new technologies. Most technologies require a learning curve and project managers are averse to doing it because it takes time to learn ...

Clinical Trials take too long to start. The clinical trial managers may not start a trial from 6-9 months to even 12 months. This is more time than it should. Research has shown that many prescription drug companies accept inefficiency. The threshold is much too high for inefficiency. Many clinical trial tools are antiquated, such as decade-old ...

A clinical trial project manager keeps track by using checklists, forms and other tools. They distribute tasks to each member of the team which is part of the SOP in a clinical trial. Updating emails and catching up with team members can be time-taking. Project Managers spend more than half their time tracking tasks, deliverables and ...

Clinical Trial costs can be controlled and reduced by following protocol. Drug trials have been done the same way for the last fifty years or so. There have been very few changes in protocols. Clinical Drug Trials need a team of technicians, doctors, nurses and administrators who do the project step-by-step and stay within the budget. They ...

Project Management of any clinical trial is usually done by trained and experienced managers who are able to mange a group of sixty people or more across the country or the world. The FDA does not require a license or certificate for project managers. Most managers must have a strong sense of coordination, organization and, most ...

Clinical Trials are mammoth projects. They may be staffed by 200 people or more. Doctors, nurses, technicians, administrators, interns and others are involved. Anyone of them can make a mistake duing the trial which can cause huge problems or ven delay the completion of the project. They are, however, controlled by the parameters of the ...

Safety precautions take during clinical trials are certainly the most important aspect. There are two groups which have scientific oversight: the sponsor and the physical investigator (doctor). Additionally, the FDA reviews them along with independent review boards. There is also “Informed Consent”. A patient consents to all the trial rules before the trial begins. Thus, the patient ...

There are many reasons why a clinical trial can be delayed. The main reason for delay is bad planning. Other reasons include: recruitment, data cleaning and proper documentation. “Lack of Efficacy” is an important aspect of clinical trials. Efficacy is the effectiveness of the drug in curing the disease. However there are many drugs which are safe but ...

Twenty tree years after the NIH created the Revitalization Act to increase the number of women and minorities in clinical trials, they still seem under-represented in drug trials. Is that still the case? There were some well-known drug trials where minorities were mistreated. Women were not even allowed to participate in trials for a long time. Based on ...

The new Trump Administration will be overseeing clinical drug policy. The big question is: How will this new administration affect clinical trials? Clinical trials are rarely influenced by the politics. Most clinical trial rules are fifty years old and well-established as are international standards. . The Trump Administration has talked about cost reduction of drugs. However, there is ...

Complex project management for clinical trials is a very critical part of the clinical drug trials planning. Most clinical trials typically run 45% over budget. There are several reasons for this occuring: 1. Lack of discipline in being able to manage a complex project. 2. Lack of understanding of your resources. 3. Financial data: Unable to capitalize nor being ...

Each country has its own rules and protocols for its clinical drug trials. Operationally, however, drug trials, including foreign ones, follow a universal standard. “Good Clinical Practices” is the manual used around the world for clinical trials. (Administrative and legal forms vary from country to country.) If the clinical trial is done well, then you can use ...

A smaller clinical drug trial could take about a year while a larger clinical trial could take many years. It depends on how the trial is executed. While there are factors that you can’t control it typically takes a year from start to finish. A smaller clinical drug trial could take about a year and a larger clinical ...

Before a drug goes to market there has to be exhaustive testing to see if the drug works and if there are any side effects. These are strictly controlled conditions. Clinical Trials is the official term for this type of testing. In the beginning Phase 1 trials is a very small trial and done in a ...

Many segments of the American population do not participate in clinical trials. These same patients also rarely give feedback on the drugs they are taking. However, that can be improved as there are several ways patients can help with developing different prescription drugs:  If you have a disease, get involved with your patient support groups.  Participate in clinical ...

Drug prices are so expensive and there are many reasons. The main reason is this: Demand for the Drugs. Drug companies have a product that you cannot live without. They charge based on what they believe people are willing to pay. People will not spare any expense to save their lives. It is how the drug marketplace ...

There are many reasons for drug delays in the product lifecycle management process. The Number 1 reason for delay for drugs coming to the market is due to clinical trials. Clinical trials take the longest time in any drug development cycle.  They are also the ones that go wrong the most often because people have to ...

Clinical trials for drugs and vaccines are quite similar on the operational side but much different on the disease side. The goals for a vaccine trial are looking at certain things which are different from what a drug would do. However, from an operational side, they are pretty much identical. Professional clinical trials specialize based on the ...

Executives and stakeholders in a drug development process are interested in two main things – seeing the overview of progress and having access to the budgetary data. Execs and stakeholders need this information to reduce risk during this lengthy process. If headway of the drug development process is stalled, halted or changes in any way the ...

The overall success of a team depends on whether it functions as a whole. A collaborative team works together and communicates. Transparency of work lends itself to communication among team members and across teams. Communication should span from the CEO, to top executives, to lower ranks of employees. With transparency, nothing will be missed. Having continuous ...

Many hands go into developing a new drug and it is over the course of several years. As a result, data winds up getting lost or work is duplicated. For pharmaceuticals and CROs, internal processes can be a challenge with information scattered among various divisions each with separate tracking systems. Developing a new drug and submitting ...

Bringing a new drug to market is not without risk. Certainly every pharmaceutical has completed rigorous analysis and determined acceptable risk tolerances for everything, from adverse events to re-submission delays. Even still, it is nerve racking making the decision to initiate new drug development research given the lengthy timelines and costs associated with a drug. ...

There are tremendous risks associated when developing a new drug. Ordinarily a drug lifecycle is between 10-12 years and teams are bound to encounter unforeseen hurdles. If teams are not utilizing the same processes and tracking their progress in the same way that can result in unforeseen delays and loss of data. It is critical that all ...

“Why do I have to keep updating the stakeholders? I just sent them a progress report a few days ago and nothing has changed…,” a question project managers ask themselves all too often. Obviously, the stakeholders have invested a significant portion of money into the development of the new drug and he/she is always in a ...

The next big market share grab will go to the organization that figures out how to reduce the number of resubmissions to the Food and Drug Administration (FDA) , and thus reduce the time it takes to get a product to market. When you have a project on a large scale such as the development of ...

Last week Aurotech attended the HIMSS 2016 conference in Las Vegas. Our purpose was to raise awareness for our company within the Health IT space. More than 50,000 people were in attendance. Including health IT professionals, clinicians, executives and vendors from around the world. An overwhelming number of people visited our booth. We featured both open ...

There have been volumes said about the benefits and woes of centralized decision-making. An equal amount has been written touting the benefits and woes of decentralized decision-making. I think it is safe to say that in different situations one decision-making approach is better than another. I would also maintain that there is space for both to ...

What? I’m not losing data! Actually you are. It is correct; you have not had a major IT system crash in years. And even if you did, systems are being backed up on a regular basis and are recoverable. And, it is true; you may have had issues with people storing data in the wrong place in the ...

In spite of recent advances in science and technology, the next great innovation in drug research and development is not going to be a major breakthrough in cancer, HIV, or some other research. That is; an increase in sustained profits will not be as a result of introducing a new breakthrough drug on the market. ...

There are tremendous advantages from being on the same page. Think of a stringed quartet. If they are not all on the same page, the harmonies produced by their instruments will not exist and the audience will walk out. The same principle can be applied to the drug research process. If all participants are not utilizing the ...

This week I attended DIA Global‘s forum on Regulatory Submission, Information and Document Management. The key take away I had was that the ongoing pharmaceutical pain points have not been addressed by any technological solution. There are solutions that target and address a subset of these pain points but the pharma industry hasn’t had an ...

The Drug Lifecycle Tracking Application is a cloud-based work management solution developed specifically for the pharmaceutical industry that maps and tracks the entire lifecycle of a drug being developed, including the FDA’s drug approval and post-approval processes and activities. DLTA provides the industry with a solution that is detailed and complete with built-in durations and dependencies, ...

Developing new drugs requires managing highly complex processes that span over several years and involves the collaboration of multiple resource groups. Having to manage this complex maze of workflows and simultaneously navigate through FDA’s regulatory requirements with no central engine has led to fragmentation within pharmaceutical organizations. A fragmented workspace leads to confusion, work duplication, and ...

Introducing The Drug Lifecycle Tracking Application (DLTA) Since the beginning of time, all technologies have a core aim of making lives convenient. And so it is baffling to us that with advances in technology and communication the largest industry in the world has become more complex. The increasing complexity of the regulated environment and in work ...

Introducing The Drug Lifecycle Tracking Application (DLTA) Since the beginning of time, all technologies have a core aim of making lives convenient. And so it is baffling to us that with advances in technology and communication the largest industry in the world has become more complex. The increasing complexity of the regulated environment and in work ...