Saturday, January 30, 2010

Neutraceuticals - Due Diligence - FDA Regulatory Scrutiny - Investor ROI

As FDA closes in on neutraceutical regulation and clinical and regulatory submission and rigor - investors, with today's economic environment require more due diligence pertaining to the product, prior to investment. Due diligence, is performed by a group of experts who examine all data, documentation, manufacturing, formulation, efficacy and safety claims, QC/QA, FDA requirements of the respective neutraceutical. In the case of FDA - someday soon, neutraceutical companies and neutraceutical products will be regulated to some degree. For the interested investor, ROI is important, however, as well, directly relates to product QC/QA, product development, formulation, manufacturing and a twist on advertising, marketing - and consumer safety essential.

Recently, I was asked to perform a quick due diligence on a neutraceutical product. What did I examine at first blush?

  • clinical and medical claims
  • clinical and medical use
  • product claims
  • product revenue
  • product formulation
  • miss-use or abuse issues
  • disclaimers
  • proprietary product documentation
  • confidentiality/non circumvent agreements
  • SEC documentation
  • private or public company profile
  • financial documentation
  • financial disclosure
  • revenue stream
  • purchase invoices
  • "the need"
  • "the perception"
  • P&L
  • shipment considerations
  • publication, abstract, literature, advertising, marketing, infomercial, brochure, statements
  • manufacturing license
  • manufacturing process and agreements
  • GRAS list for import and export of product substance
  • CMC - chemistry, manufacturing and controls
  • "rights" to active ingredient
  • product line of the company
  • FDA correspondence
  • claim substantiation
  • claim longevity
  • claim integrity
  • clinical studies to support claims
  • consumer safety
  • consumer adverse reports pertaining to product use
  • endorsements
  • testimonials
  • data
  • documentation
  • company history and background information
  • company operations and staff
  • Officers of the company, CEO, CFO, COO, CSO, CMO, etc.

The "quick" due diligence performed for the neutraceutical in question was essentially a snapshot of a QC/QA, "check-list audit" process and procedure that would be required by FDA for a drug, device, biologic, vaccine, technology - similar, indeed.

The need for due diligence is clear for the FDA and the investor. The process, procedure and audit type is dependent on the neutraceutical and the claim. Whether FDA or investor, quality is a must. Ensurance of subject/patient and/or consumer safety is critical.

Friday, January 29, 2010

Neutraceutical - How close to Pharmaceutical FDA Rigor?

Recently, I was asked to review with FDA rigor and "investor" interest and due diligence, several NCEs for various therapeutic indications, all in areas of unmet medical needs, inhalation devices, state of the art and several neutraceutical products.

For this blog, lets focus on neutraceuticals -

Interesting enough, FDA is closing in on neutraceuticals. These are products that are generating revenue on the market, manufactured by top pharma manufacturing facilities, formulated and contain active substances which in addition to the primary product "marketed" claim - lowers cholesterol, while building muscle and correcting hormonal balance - as well demonstrates efficacy or benefits in other areas, for example CNS - demonstrates a sense of well being in patients diagnosed with bipolar, schizoaffective, psychosis, etc. These are products that have not traveled the clinical and regulatory pathway with FDA rigor.

At some point in life cycle of the neutraceutical and because of the "apparent" medical benefit of the neutraceutical, FDA will step in and demand that the formulation, the product, become quality-controlled and assured and regulated. FDA will want the neutraceutical company to submit a clinical and regulatory submission and product filing.

It will happen - it is just a matter of time. In the last two years, across my desk, four neutraceutical companies in business for at least 10+ years have been contacted by FDA to provide a clinical development and submission plan for filing.

If you are a neutraceutical company, stay tuned - it will happen to you. If it does, FDA will want to see in a realistic time frame, your intent to comply with their request for FDA rigor. I will speak about how to comply and the components of the filing in the next several blogs. I will as well, provide a brief checklist on due diligence from an investor's point of view as well.

Wednesday, January 27, 2010

Clinical and Regulatory Biostatistical Submission Data Display - The Proper Use of Graphs

The design of a good graphic display for clinical and regulatory submission data must show the FDA reviewer the data and encourage the reviewer to think about the substance and storyline as described in the Clinical and Regulatory Development Plan and the Statistical Analysis Plan. What are you trying to convey to the FDA reviewer - don't be afraid to show it in a well designed graphic display.

Good Clinical and Regulatory Submission Graphs should:
  • emphasize data and storyline and not methodology, technology or "tricky" analytics that beat up the data for clinical and statistical significance
  • not distort what the data has to say
  • be closely integrated with statistical and verbal descriptions of the dataset and database
  • present many numbers in a small space
  • make large datasets and databases, integrated or otherwise, coherent
  • reveal the data in many levels of detail.

Just as good medical writing is a result of frequent communication between the medical writer, SAS programmer, clinical safety and efficacy and the QC team member - the same holds true with the development and creation of a good analytical graph - there must be frequent communication between the SAS programmer, analyst, QC, clinical safety and efficacy - for whom? - for the benefit of the FDA reviewer.

With regard to clinical and regulatory submissions - there is the overall submission team and additionally, there are submission subteams that must be responsible for the clear presentation of submission data from their respective areas of expertise.

"It takes a team to win".

Tuesday, January 26, 2010

Clinical And Regulatory Submission Data - Design of Good Graphic Display

For good graphic design for clinical and regulatory submission data strive for quality by focusing on the following points to consider:

  • a well designed presentation of interesting data is a matter of substance and storyline, of biostatistics and of design
  • complex ideas should be communicated with clarity, QC, precision and efficiency
  • graphics should give the team reader and FDA reviewer the greatest number of ideas in the shortest amount of time while using the least print in the smallest place - pertaining to data density and presentation for clinical and regulatory submissions - the adage is "give the FDA reviewer a lot of white space on a page"
  • the true data must be shown and used - for only then will the data display a precise biostatistical point
  • most graphs, and therefore most data, when presented with clarity are multivariate - well thought out design and display of accurate, clear data even multivariate in nature will present well.

"The data must be true" - yes, and the first step to accomplish a graph of excellence is to use QC early in the collection of the data to be included as points in the graph.

Monday, January 25, 2010

Clinical and Regulatory Submission Biostatistical Display

Graphs communicate. There is both an art and a science to the accurate and appropriate choice of clinical and regulatory submission visual display of biostatistical display.

The Purpose of Graphs

A good graph will:
  • save the user time - information is sifted and refined
  • gain user attention - easy and pleasing to the eye to generate reader motivation
  • show relationships and permit study of the data
  • the user should be able to look for regularities and irregularities with in the data
  • study data points and their spatial relationships to each other may reveal meanings not otherwise observed
  • in deciding whether to use a chart or a graph - the form which best shows the relationships should be used
  • suggest new ideas - a good graph might reveal connection that otherwise would not be perceived
  • make efficient use of information - display fundamental relationships by way of visual convention.

Three things will happen with a good graph:

  1. the graph will be studied
  2. the graph will be accepted
  3. the graph will be remembered.

Remember, clinical and regulatory submission data points are the building blocks of a graph and as such a QC (SOP) procedure must be developed and utilized to ensure accuracy in data entry, programmatic presentation and graphics. Graphs are most often "double" program validated first, followed by a second, final data QC step.

Friday, January 22, 2010

Regulatory and Compliance - Inhaler Drug Device and Delivery Systems - FDA

When considering a inhalation device or delivery system for your drug, here are important points to consider with respect to device or delivery system design, flexibility, user-ease, single or multidose compartmentalization, drug stability, lock-out measures to counter patient abuse, miss-use and street value. As per FDA and by guidance, guideline and requirement, FDA will expect the following attributes to be thoroughly investigated, controlled, tested and achieved with quality and statistical significance - results, data and documentation included in your regulatory submission and filing.
  • High efficiency of delivery
  • High accuracy of delivery
  • Dose reproducibility
  • Dose feedback
  • Coordination independence
  • Flow independence
  • Orientation independence
  • Support all populations, elderly, pediatric, compromised, etc.

Tuesday, January 19, 2010

Transfer of Clinical and Regulatory Submission Data and Documentation for QC

Clinical and regulatory data and documentation presented for QC must be version-controlled, protected and transferred from one site to another, one location to another, worldwide, with proper security via standard process, procedure and acceptable media.

For QC to be effective, clinical and regulatory submission data and documentation must be transferred via acceptable media:

  • floppy disk
  • paper
  • CD
  • DVD
  • DLT
  • shared secured, password protected drives
  • FTP servers - secured, password protected
  • a validated, process-controlled documentum tool
  • a validated, process-controlled publishing tool
  • a validated submission-ready template
  • pharma servers - proprietary and protected.

Clinical and regulatory submission data and documentation for QC must not be transferred at any time or under any circumstance via unacceptable media:

  • email
  • excel spread sheet
  • fax
  • telephone
  • blackberry
  • power point slides.

According to QC and GCP (Good Clinical Practice) guidance, clinical and regulatory submission data and documentation must be securely transported and version-controlled. Any media that allows modification to the data and documentation, before, during or after transport is unacceptable according to ICH, GCP, SOP, FDA standards. A QMP (Quality Management Plan) SOP outlining the process, procedure and transport of clinical and regulatory data and documentation is recommended. Adherence to the SOP is strongly advised without deviation.

Sunday, January 17, 2010

Clinical and Regulatory CTD Submission QC - Why QC?

Why QC your clinical and regulatory submission - data, documentation, summary module, CTD?

The result of effective QC -
  • The final product, your clinical and regulatory submission is credible, accurate and consistent with previously submitted documents and data worldwide - with QC review - inaccurate data and global inconsistencies are caught and corrected
  • Highly complex, complicated, summarized clinical integrated submission data and documents are inherently prone to errors and inconsistencies - with QC review - these errors are caught and corrected
  • SAS programmed integrated data, tables, listings, graphs and figures, summarized clinical and regulatory submission "storyline" statements, interpretations and conclusions appear sensible, however, clash after many team reviews - with QC review - inconsistent statements, interpretations and conclusions are caught and corrected
  • Module to Module data and documentation errors arise in CTDs - with QC review - intermodular and intramodular errors are caught and corrected
  • Clinical Summary to Nonclinical Summary to CMC Quality Summary - summary to summary inconsistencies arise during the course of submission - with QC review - summary inconsistencies are caught and corrected.

    The QC team are "gate-keepers" of all data and all documents and track errors, statements, interpretations, corrections, versions, etc., so the final data, documents, clinical and nonclinical, CMC summaries, CTD Modules are clear, consistent and accurate and are QC final with respect to QMP, SOP, ICH, CFR, FDA compliance and quality standards.

    The QC team provides a unique opportunity as gate-keepers - the team reviews all data and documentation in the clinical and project submission process while building your CTD. The process of QC is independent of pharma functions and CROs - a clear advantage.

Saturday, January 16, 2010

QC Provides ROI and Prevents Clinical/Regulatory Submission Pitfalls

The utilization of QC (quality control) pertaining to your clinical/regulatory submission, program, project, data and/or documentation, daily and routinely, is a must and the results are - ROI (return on investment), dramatic reductions in costs, avoidance of pitfalls leading to erroneous data and process and agreed upon timelines are met.

QC objectives, plans and benefits (to mention a few):
  • easy to forecast QC pitfalls when not utilizing QC
  • each data, table, listing, graph, figure and/or document must have a QC plan tailored to catch errors and provide accuracy with current and previously submitted clinical and regulatory submissions and filings
  • easy to forecast areas of significant QC findings and where and how data, statement, format and documentation errors are more likely to be found
  • easy to resolve QC findings
  • easy to track QC findings
  • easy to implement QC findings
  • easy to follow-up the implementation of QC findings throughout your clinical/regulatory submission when dealing with hundreds of thousands of data points
  • easy to demonstrate "streamlining" time, cost, manpower, version, template, effort, data, statement, clear and present presentation, accuracy, consistency pertaining to your data and documentation as a result of QC
  • easy to follow the plan and reap the benefits of quality-controlled data, statement, format, template and documentation pertaining to your clinical/regulatory submission.

Appropriate QC planning and utilization is a must. For example, a waste of QC time is to QC a draft version of a clinical study report, clinical study appendix, a safety narrative, a SAS programmed table, a clinical summary of safety and efficacy, a summary of bioanalytics, a summary of clinical pharmacology, a clinical overview, a subject patient profile, a database listing, a database - to mention a few components, "too early" in the writing and development stages - QC must be performed on the appropriate version, a mature version, a near final version.

The first QC round must be utilized for gross QC (procedure/objectives found in the QC plan) - the second QC round must be focused on QC resolution of the findings, correction, implementation, tracking and finalization.

Two rounds of QC is optimal for most data and documentation.

A third round of QC may be needed if time is tight, the length of the document is too long, for some reason, exceeds the recommended number of pages and/or the document is heavily populated with data. Time, length and data density issues occur due to miss-managed project, writing and SAP (statistical analysis plan) - and are items that must be controlled by the pharma/CRO teams prior to the start of QC - so that QC is effective.

Friday, January 15, 2010

The Benefits of QC - Clinical/Regulatory Submission

The benefits of quality control of clinical/regulatory submission data and documentation is obvious, speaks to ROI - return of investment and ensures fileabilty of the dossier.

The obvious benefits are, to mention a few:
  • fast track FDA review
  • fast track approvals
  • less Q&A, post-file
  • less Q&A with advisory committees
  • less Q&A with expert panels
  • less Q&A post-approval
  • clinical submission content is credible
  • cost effective
  • time effective
  • on time team review
  • timelines are keep, fast tracked
  • provides, well-controlled data and documents
  • ensures confidence in the accuracy of data and documents
  • ensures confidence in the accuracy of current and previously submitted clinical submissions and filings
  • provides user-friendly data and documents to the end user - FDA, Worldwide
  • coming in under budget.

QC is different than QA. Often pharma mistakes the two tasks, both are necessary, both are essential, both are important points to consider in the early planning stages of clinical/regulatory submissions.

Wednesday, January 13, 2010

International Regulatory Guidance - EMEA ICH E9

The international regulatory guidance pertaining to the creation and development of the Global Integrated Database (GIDB) for clinical submission is EMEA ICH E9. When creating the GIDB and Integrated SAP (Statistical Analysis Plan), while utilizing the guidance provided in EMEA ICH E9 - it is important to develop a strong:
  • methodological approach
  • statistical analysis plan that will demonstrate significance pertaining to objectives and endpoints
  • appropriate and version specific and accurate tools for programming TLGFs (Tables, Listings, Graphs and Figures) - SAS Version 9.1 and 8.2, current and previous version, respectively
  • standardized, validated program of analysis
  • QMP - Quality Management Plan
  • "Change" Plan - how to manage
  • GIDB Mapping Plan
  • GIDB Coding Plan
  • GIDB Dictionaries, MedDRA, WHODRL, etc.

The guidance will "suggest" the creation of two SAPs for the GIDB - one developed for the programming, presentation and pooling strategies for safety data and one for efficacy data. It is important to communicate with FDA early in the development of each GIDB SAP to agree on the programming, presentation and pooling strategies pertaining to clinical submission data. Communication with FDA concerning the GIDB can begin as early as the End of Phase 2 Clinical Studies or at the beginning of the Clinical Phase 3 Program when the "final marketing image" of the investigational drug is clear and decided and the dosing, safety and efficacy objectives and endpoints are final.

Tuesday, January 12, 2010

Clinical Submission Global Integrated Database (GIDB)

With respect to the final QC controlled and QA clinical submission GIDB and "locking the database" - is a "Database Lock Form" required?

The answer is - yes. Remember, at the clinical study level, when a database is locked, a "Database Lock Form" is required. The same holds true at the submission level with the GIDB Lock.

The Database Lock Form will include:
  • Sponsor name
  • Project name - usually the name of the investigational drug
  • Database - GIDB - Global Integrated Database
  • Version
  • Statement - "After checking all items relative to the data management activities, the clinical manager and the data manager (pharma, CRO, consultant or otherwise, in-house or outsourced) indicate that the database is final and request it to be locked."
  • Signed and dated by the clinical manager
  • Signed and dated by the data manager
  • Signed and dated by the biostatistician that wrote the SAP (GIDB) - the person performing the "Lock"
  • Time and date of the GIDB Lock.

There are no changes allowed to the GIDB after the time, date and signatures are received and the Database Lock Form is fully executed on the "same day".

Make no mistake in the process, procedure, time, date or otherwise - it will invalidate the GIDB - now, the clinical submission GIDB has serious data integrity issues - sometimes reparable with GCP correction and communication with FDA, sometimes irreparable, sometimes - "a do over - the GIDB has to be created from the start" - first data point, first clinical study. Serious cost, timeline delays, quality management issues, perception of FDA - not good.

More to come from the Desk of Dante pertaining to the Clinical Submission GIDB - important points to consider.

Monday, January 11, 2010

GIDB - Global Integrated Database - Clinical/Regulatory Submission

A point to consider which is often asked and debated by pharma when considering the development, structure and SAP (Statistical Analysis Plan) of the Clinical/Regulatory Submission GIDB (Global Integrated Database). The GIDB is an integrated database which captures all data from Clinical Studies, Phases 1,2,3. The GIDB includes all data for clinical safety and clinical efficacy. FDA will often expect several "GIDBs" - one for safety and one for efficacy. The GIDB for efficacy will include data for Clinical Studies, Phase 2 and 3. The GIDB for safety will include data for Clinical Studies, Phases 1,2,3 - yes, FDA will expect, a GIDB for Phase 1 as well.

It is expected by FDA to "have some pooling across all studies" for Phase 1 safety. Most pharma disagree with the Phase 1 GIDB because they feel that Phase 1 studies are too heterogeneous in design and captures information for safety and tolerability, not detailed , much like a POC study.

However, the FDA explanation and reasoning is that even in Phase 1 an AE (adverse event) may appear and for FDA that is their main concern to make sure ALL AEs are captured, reported, reviewed and researched - the ultimate goal is not to approve a drug - it is patient safety.

Make sure you correspond with FDA, verbally and in writing as to this requirement. It is a point of consideration to the overall filing - it can trigger a RTF (Refusal to File) if FDA requested a Phase 1 GIDB and the pharma company did not include one in the filing.

Careful negotiation with FDA pertaining to the content and the TOC of the GIDB, the pooling is important. The GIDB must carry the "storyline" of the clinical submission and should be equivalent to the eventual message in the label of the drug. With careful planning and clear statistical strategy, one can negotiate with FDA how to present the data in the best way for clarity, however, don't fall short on the importance of including all safety data at all stages of clinical development. Under-reporting for any reason is not tolerated by FDA.

Saturday, January 9, 2010

The Difference between TGA and EU CTD Filings

A client of mine just asked me several days ago, a drug was purchased from a company that was in distress, the "price was right". The drug was just approved in the EU. The client wanted to submit the same CTD dossier to TGA (Australia).

The client is correct on one hand and needs advice on the other. In my experience to handle sections with "identical" content for TGA, EU, FDA, others - consider first that nothing is a cut and paste, nothing is identical, nothing is exactly the same from one submission to another. Second, to save time, map similar sections from one document to another, perform a cut and paste activity from one document to another and modify as needed. A QC must be performed to deem this documentation QC final and QA certified.

The answer to the larger question - yes, TGA is happy to use the CTD documentation from EU for their review, however, there are certain sections that must be, by requirement expanded. One of these sections is clinical laboratory data, ECG and otherwise. Another difference between EU and TGA, is "narratives" - narratives (several types) may be included in Module 1 for TGA, not so with EU. So, here are two examples, the former pertaining to expansion of data and the latter pertaining to a change in content location. The point, whether minor and major - there are differences.

Communication with TGA is a must to understand fully the target TOC, the arrangement and the exact organization for the format and the entire clinical submission. Always request correspondence, minutes to the meeting, TC or face to face - this information becomes critical at the time of filing and RTF and completeness. QC the clinical submission - all Modules - for accuracy and consistency across all data and documents.

Friday, January 8, 2010

Medicines for Children - EU Pediatric Regulation - EMEA

In the previous communication, information pertaining to EU PIP was provided to the readers. A bit more about the PIP Regulation - yes, it is new - entered into force in the EU on 26 January 2007.

The objective of the Pediatric Regulation is to improve the health of children in EU by:
  • facilitating the development and availability of medicines for children aged 0 to 17 years
  • ensuring that medicines for use in children are of high quality
  • ethically researched
  • authorized appropriately
  • quality-controlled
  • quality-assured
  • improving the availability of information on the use of medicines for children


  • subjecting children to unnecessary clinical studies and clinical trials
  • delaying the authorization of medicines for use in adults.

The Pediatric Regulation dramatically changes the regulatory environment for pediatric medicines in EU.

In the next communication, I will provide opinion and key aspects of the changes impacting the regulatory environment for pediatric medicines in EU.

PIP EU - Pediatric Investigational Plan - Clinical/Regulatory Submission

Due to recent legislation in the EU governing the development and authorization of medicines for use in children, a PIP now needs to be written and an opinion adopted, prior to clinical/regulatory submission of a MAA - Marketing Authorization Application.

The preparation of a PIP presents the unique challenge of concisely presenting information on the disease to be treated in children and current knowledge of the drug being developed, together with assembling a convincing rationale for the pediatric development program being proposed.

PIPs can be developed, prepared and submitted in most therapeutic areas, applicable to pediatrics.

In several ways, the PIP is more complicated than most clinical/regulatory submissions. Therefore, it is strongly advised that all pharma sponsor functions be proactively involved. Literature based information, post-marketing information, safety surveillance information and otherwise as well as previously submitted and approved filing for the adult in all indications, if applicable, are readily available to the writing and QC teams at development start of the PIP.

Acceptance and use of the PIP clinical/regulatory submission in the EU is in its first year and I believe just in the recent past, the first approval was awarded, so the SOPs, the structure and content are still under scrutiny and is currently monitored and reviewed with rigor.

From the Desk of Dante and Dante Colleagues.

Monday, January 4, 2010

Clinical Documentation - Medical Writers and QC (Quality Control)

A clinical development program/CTD clinical submission for drug, biologic, device, vaccine, gene-product, stem cell, monoclonal and otherwise, require a range of documentation, regulatory, non-regulatory, clinical, non-clinical, major and minor, all require process and procedural adherence, all require QC (quality control) of data, all require QA (quality assurance) of guidance completeness and compliance. All require tracking and monitoring. All require project management for realistic timelines, resource and capacity. All require dedicated medical writers.

The range of documents required for a clinical development program which by normal progression populates your CTD (Common Technical Document) Clinical Submission includes but is not limited to the following -

  • CSP (Clinical Study Protocol)
  • CSR (Clinical Study Report)
  • CTR (Clinical Trial Report)
  • CTD Module Summaries
  • Informed Consent Form
  • Narratives
  • Subject Patient Profiles
  • PIP (Pediatric Investigative Plan)
  • RMP (Risk Management Plan)
  • Manuscripts
  • SmPC (Summary of Product Characteristics)
  • USPI (United States Package Insert)
  • Posters
  • PSUR (Periodic Safety Update Report)
  • ASR (Annual Safety Report)
  • IB Investigator Brochure
  • IMPD (EMEA Product Dossier)
  • CTA (Clinical Trial Application)
  • IND (Investigational New Drug Application)
  • NDA (New Drug Application)
  • GIP (General Investigative Plan).

It is imperative to have your clinical development team and your clinical submission team work together at the beginning of your clinical development program (CDP) through to filing to ensure efficiency and quality.

It is imperative that expert medical writers and QC work together in the early document development stage, preparing thoughts and clear structured statements. Thoughts and statements that are real and can be supported by data.

By organizing the medical writers and QC teams early in the development of your documentation, it will streamline the later stages of the CTD and streamline all documentation.

Using the same teams, medical writers and QC and keeping those teams together until the filing of the dossier will ensure overall efficiency, consistency and accuracy.

When does QC begin? Which documents should be QC? At the beginning of the clinical program and all documentation, respectively.

What is the benefit of having early medical writing and QC teams? - The benefit and result can be easily measured in metrics pertaining to ROI (return on investment) -

  • # of document revisions are reduced
  • # of QC cycles are reduced
  • # of document drafts are reduced
  • # of team reviews are reduced
  • time to filing is reduced
  • costs of the CDP and CTD are reduced
  • impact on employee manpower is reduced
  • impact on pharma organization is reduced
  • CRO outsourcing, timelines, efforts, materials, consultants, tasks are reduced.

Saturday, January 2, 2010

Global Project Team Leadership and Task Management for Clinical Submission

Global Project Management occurs across all sponsor functions and all vendors.

The "gate-keeper" role of a global clinical submission project leader is to lead the team and manage the functions, the issues, the changes, the processes, the procedures, especially monitor and QC the data and the documentation. "On-time" timelines and targets will be achieved if the practice of leadership, management and communication are performed religiously, thoroughly, completely, logically, logistically and concisely. Find the weakest link, whatever and where ever and "support" the link.

Global Project Leadership and Management for Clinical Submission occurs across all sponsor functions and all vendors, all tasks, all deliverables, all responsibilities, all accountabilities, all teams, contributing to the filing and the eventual submission -
  • Regulatory
  • Clinical
  • Nonclinical
  • CMC
  • Data Management
  • Statistics
  • Programming
  • Project
  • Publishing
  • Quality Control
  • Quality Assurance
  • Contributing Functions
  • Outsourced, Contractors, Consultants, Vendors
  • All Data
  • All Databases, study level and global integrated
  • Experts, Advisory Committees, Opinion Leaders
  • Adjudicators
  • Timelines, Tracking, Milestones, Monitoring, Communication, FDA Correspondence
  • Pharmacovigilence.

Did I miss anyone, any team, any task, any function?