Clinical Schedule Template: Fill & Download for Free

I’ve run a successful outpatient medical practice for 10+ years now and I would say these are the things that make a clinic run late:Poor scheduling template and /or failure of the schedulers to follow it. If you don’t match the type of patients with the time allotted for them, you will get behind. Certain type of appointments take longer, especially ones where you expect to perform a procedure. Building a template takes time and experience. There is no out-of-the-box solution to this. Physcians and office managers need to pay attention to how a given template works and adjust constantly.Late patients. It’s like a row of dominoes: One patient being late can make your entire clinic run late for the rest of the day. Two late patients compounds it, and so on. We have a policy that if you are 15 minutes or more late, you have to option to reschedule or wait until the patients who are on time have been seen. Some patients are angry (“It’s not MY fault I’m late, there was traffic/my kids were sick/etc., etc.”) but most understand.Unrealistic expectations of patients. My front desk, my MAs, and I all let the patient know what sort of appointment they are there for. I don’t know how many times I hear, “Well, I know I’m here for XZY but could you please also address ____.” or “But I didn’t get through every item on my list!” If I’m not going to be late for the next patient and/or I still have time to address what they are asking, I will do it. If not, I tell them that we’ll need to make another appointment to address that. Again, most are understanding but some are indignant. The lattermost are ones you don’t want to come back anyway, to be honest. We as physicians are not good at saying no but in order to be fair to all of our patients, we need to say no sometimes. I wish that more patients understood this.I know that some people want to hear answers like: Reduce doctors’ paperwork burden, doctors are greedy and try to fit in as many patients as possible, doctors value their time more than mine, etc. That may be true for some but not most physicians. We want our clinics to run smoothly and on time, too. It’s stressful to run behind.

A New Drug Application (NDA) follows the same format as a Biologics Licensing Application (BLA). Nowadays, the applications even go to the same division. The notable difference is that NDAs fall under the Food, Drug, and Cosmetic Act where as the BLAs fall under the Public Health Service Act. The BLA will also have a more extensive emphasis on facilities and process. That said, I can completely see a scenario where the NDA would basically do all of the same steps and reviews as a BLA. Since both a NDA and a BLA follows the same structure outlined in the International Conference on Harmonisation (ICH) for the Common Technical Document (CTD), they have the same flow and the same material will go to other agencies like the Marketing Authorization Application (MAA) to the EMA and the JNDA to the PMDA.For more details I would suggest looking at How is the FDA approval process for New Drug Applications (NDAs) different from Biologic License Applications (BLAs)? The only decent figure about the differences produced by an “expert” that I don’t trust is the followingAnyways the timeline. The answer really depends on how ready the different bodies are and how they’ve been generating their data and how well these different bodies communicate with each other.While the clinical teams are filling out the clinical summary (2.5/2.7) in Mod 2, the PD/PK teams and Tox teams are doing their own studies (2.4/2.6). Many of those studies are determined as the clinical data comes back. It’s further broken into the Quality, Safety, and Efficacy. All of this work operates completely separately from Quality sections which comprises of Module 2.3 and Module 3 associated with the process development and manufacture. Since the process development is linked with the clinical material used for the trials and the data from the clinical trials is necessary to determine what would be considered Critical Quality Attributes that would influence the Target Product Profile of the drug, you really need the two units to communicate with each other all while you’re operating under triple blind conditions.The CTD consists of a huge number of sections from units that have completely different timelines. The “structure” of the application is associated with each individual segment of the above CTD and it’s further broken into smaller subsections that will get updated during the drug lifecycle. Ideally, you have independent minions like me that handle each section.This is a schematic of a subteams for just a Module 3 NDA writing team.Still with me? Let’s assume that all of the data comes back in good shape and there is shockingly no need to redo any studies.If you were smart and forward thinking, a company that probably has gone through several mergers and acquisitions, 10 years of studies performed by hundreds of scientists, written by hundreds of authors, and uncountable number of handoffs, you should have the foresight to have a standard formatting guide using standard templates that makes all of the reports sound like it was written by one person AMIRIGHT?Thus begins the long and arduous process of an army of technical writers trying to find all of the relevant source documents that have been accumulated over the years and copy and pasting them into the relevant sections and copy editing them so that it doesn’t sounds like hundred people wrote individual sentences and then decided to string them together (although that’s probably what just happened).Presumably you’ll probably want to check that they didn’t accidentally delete any numbers or provide too much information. Chances are you’ll have an independent reviewer look over all of those numbers and confirm that they are the same.By this point you’ll have thousands of pages of individual sections. It should just be a simple PDF rendering and then merge! Apparently the “Publishing” of the eCTD process itself takes several days. Part of the challenge is the the individual sections hyperlink to each other and are connected by some XML backbone thing to make sure that it’s all connected or something. IT’S COMPLICATED.All of this happens with a simple premise: if the writing is not good, it means that the reviewers will need more time to review and they will need to ask more questions and that adds time to the review cycle and prevents your drug from getting to the patients that need them.Now for the question. How long does it take? How long does it take for a small team of researchers to write a manuscript? How long does it take for for a long team of scientists to coordinate to write a manuscript? I think that’s the right comparison. ATLAS and CMS are probably the other extreme when it comes to writing 1,000 author manuscripts. There you had hundreds of individual teams ensuring that their sections were accurate all while being coordinated by some master section chiefs. At the same time, if you did all of the writing correctly ahead of time, you should have all of the individual sections ready to go and easily merged.One of the great problems about the completion of Phase 3 trials is that they tend to be unexpected. Companies will schedule “checks” where select people will look at the data and decide whether or not they should unblind the data. Even after the data is unblinded and the company decides to kill the program or shift everyone over to the dose arm, the trial is still “going on” as they monitor the overall survival of the active population.But if I had to imagine writing a NDA from scratch, it sounds like it would take around half a year to ready a submission.But that’s not actually what happens. Under the FDA’s fast track program, they will accept rolling submissions. Thus, if they feel that the prospects of the clinical trial are looking good, OR they have already granted an accelerated approval and they are looking for an expansion of the application, they will take a look at the already completed section. Typically, the FDA will only look at the non-clinical and quality data after efficacy has been shown but if they are feeling good about the power of the efficacy data, they’ll start looking at the other sections early.Thus, companies will start writing these sections ahead of schedule at risk. Likewise, for the clinical data, they’ll probably prepopulate the reports and sections and leave the tables and conclusions empty until the data starts rolling in. Likewise, the non-clinical groups will write what they can in their main sections and fill in the gaps as their final studies come back together. These groups also have the opportunity to go back into the archives and revise all of their older source documents so that they follow the same style guides as the newer sections so that their data is ready for the Tech Writers once they become available. Those teams are then going to sit on their sections until the clinical results are announced and they’ll race to push out the NDA. As the individual reviewers finish their reviews the queries will go back to the companies where they will try to quickly provide a response to minimize the review time. At the end of the review process when all of the inquiries can come back and the FDA is satisfied with the quality of the product, they’ll start to finalize the label and look at the final steps of drug release.Using Merck’s submission strategy, they started writing their filing before they actually qualified their process via their PPQ. [1] Thus, they wrote up their process characterization and stability work before they achieved a process lock and demonstrated process validation. A huge risk if their process didn’t work.So practically speaking, the NDA is being written the entirety of the Phase II/III clinical trials. Since no one knows how long those trials can last, it could be a year, it could be 5. Either way, people are probably going to be locked up in rooms with lots of Red Bull typing away into the night hoping to get their drug to people as quickly as possible.Footnotes[1] http://c.ymcdn.com/sites/casss.site-ym.com/resource/resmgr/WCBP_Speaker_Slides/2015_WCBP_ToblerScott.pdf

There is a good deal of software for healthcare, but the most established one is Zendesk. Unlike their normal helpdesk software, it tailors the healthcare help desk with patients in mind. The tool helps medics and other clinic members to threaten patients more thoroughly by giving fundamental information about the individual in advance. It allows medical workers to speed up many processes by equipping them with an advanced schedule.And yes, Zendesk can be HIPAA compliant, provided users configure the solution correctly and enter a business associate agreement with Zendesk.Although Zendesk is not created specifically for healthcare, it can be as mobile and as flexible as needed to make team and patient management simple, fast, and possible from any smartphone. The product has already integrated nice e-mail templates. So it helps to send emails, create email marketing campaigns, and manage deals right on the go.Advantages of using Zendesk in healthcare:Wide industry reach and lots of integrations.Enhanced user experience.Plenty of support resources.