Navigate Compliance Waters

Widler & Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you.

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  • 07 July 2015
  • 3612
Widler & Schiemann AG support WHO on GCP Training
Two successful workshops conducted in the Philippines and Nigeria
  • 02 July 2015
  • 3702
FDA Releases Guidance for Acceptance of clinical Data from trials outside the USA
New Guidance issued by FDA for sponsors of medical devices who want to use their clinical data from trials outside the US for an FDA submission
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  • 20 June 2015
  • 4295
EMA on Gene Therapy
The European Medicines Agency invites feedback on their latest draft guidance
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  • 15 June 2015
  • 3816
Master Protocols proposed by FDA
FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs
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  • 10 June 2015
  • 3911
Beat Widler presents at Drug Development Expert Workshop in Frankfurt, Germany
Risk-based study management – dos and don’ts
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  • 05 June 2015
  • 1290
WHO Workshop in Manila
Beat Widler conducts GCP Workshop on behalf of WHO in Manila
  • 05 June 2015
  • 3311
New FDA BIMO Slides are out!
The new Bioresearch Monitoring Metrics for 2014
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  • 01 June 2015
  • 3552
FDA Releases Guidance for Clinical Trial Sponsor-Investigators
New Guidance issued by FDA for investigators on how to file an IND (investigational new drug) application
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  • 20 May 2015
  • 3547
Endpoint Adjudication Methods used in Clinical Trials for 69% of the NMEs approved by FDA and 41% by EMA
Beat Widler with Ken Getz from Tufts University and colleagues from our partners published a research article on DIA’s Therapeutic Innovation & Regulatory Science, Journal
  • 12 May 2015
  • 3187
WHO Statement on Public Disclosure of Clinical Trial Results
Ethical imperative and timeframe definitions
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  • 08 May 2015
  • 3470
Providing patients with outcomes of clinical trials
Initiatives to informing patients after their participation in a clinical trial of the outcome
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  • 04 May 2015
  • 4086
Faster Clinical Trial results reporting
Using TrialScope Convert can help you speed up your clinical trial results – and it is free!
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  • 03 May 2015
  • 3759
Clinical Trial Oversight Summit Boston
Peter Schiemann to speak at the Clinical Trial Oversight Summit, Boston, MA, June 1-3, 2015
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  • 30 April 2015
  • 3597
REMS Update
Modifications and Revisions on the FDA Guidance
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  • 20 April 2015
  • 3392
FDA invites comments on their Guidance for Clinical Trial Sponsors:
Establishment and Operation of Clinical Trial Data Monitoring Committees
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  • 15 April 2015
  • 3730
RbM Data reveals: Site screening Due Diligence improves patient dropout and retention
A way to utilize RbM for patient retention
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  • 10 April 2015
  • 3542
Case Study: Using RbM to evaluate and predict site engagement
RbM can do more than just deploy monitors
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  • 05 April 2015
  • 3468
FDA Draft Guidance on the use of electronic Informed Consent
A Q&A guide on the use of electronic Informed Consent in Clinical Investigations
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  • 31 March 2015
  • 1310
Swiss Federal Office for Public Health launches new web site
The webpage has been completely revised and contains now also tools for researchers! These are the wizard to help categorise research projects, examples of trials and a glossary in four languages and more… Visit the website
  • 31 March 2015
  • 3811
Sentiment Analysis: Understand your Healthcare Customers
Beat Widler co-authors article on Applied Clinical Trials
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  • 21 March 2015
  • 3531
FDA - CTTI recommendations for GCP training
How frequently is GCP training needed and what should be included?
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  • 14 March 2015
  • 4768
EMA updated their Q&A on GCP webpage
How should data be presented when they are sent to the inspection team prior to a GCP inspection requested by the CHMP?
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  • 07 March 2015
  • 3789
Does the TransCelerate RbM Guidance Offer Standardization?
Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post
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  • 26 February 2015
  • 3237
New FDA Draft Guidance on Expanded Access:
Individual Patient Expanded Access Applications: Form FDA 3926
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  • 23 January 2015
  • 1262
RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management
You can read this document and others in our Resources/Publications section. Read the pdf Visit the publications section
  • 14 January 2015
  • 3447
Applied Clinical Trials
RbM Guidance Document published on “Applied Clinical Trials”
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  • 10 January 2015
  • 3269
And finally another FDA Final Guidance for Industry
Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
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  • 01 January 2015
  • 3246
Another FDA Final Guidance for Industry
Providing Regulatory Submissions In Electronic Format -Standardized Study Data
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  • 24 December 2014
  • 3266
Season's Greetings!
The whole Widler & Schiemann Ltd. team wishes you happy holidays and a successful and prosperous new year 2015!
  • 22 December 2014
  • 3397
FDAs Final Guidance for Industry
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format
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  • 18 December 2014
  • 3821
Exception From Informed Consent Requirements for Emergency Research
This is a 17 Nov 2014 update from the previous MAPP version dated 4 Feb 2003
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  • 09 December 2014
  • 4532
Rare Pediatric Disease Priority Review Vouchers - Guidance for Industry
FDA has published its draft guidance on rare pediatric disease priority review.
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  • 03 December 2014
  • 3331
European Guidelines on ePrescriptions
Guidelines on ePrescriptions were adopted by the European eHealth Network on 18th November 2014
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  • 14 November 2014
  • 4591
FDA GCP Training
The FDA conducts GCP training on site, but also provides on-line training and a whole training program
FDA Clinical Investigator Training CourseFDA's Clinical Investigator Training Course Read
  • 05 November 2014
  • 3944
New Data Dashboard Tool Shares FDA’s Inspection, Compliance and Recall Data
Inhalt: As part of FDAs commitment to transparency, FDA is pleased to announce that they have released a new online tool to provide insight into their compliance, inspection, and recall activities.
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  • 03 February 2014
  • 1526
Proposed changes to Directive 2001/20/EC
The European Commission, Parliament and Council published the proposal for repealing the Directive 2001/20/EC on "Clinical Trials on Medicinal products for Human Use". Download the document here:
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  • 01 December 2013
  • 1507
Risk-based Quality Management
EMA publishes final version of their Reflection Paper on Risk-based Quality Management in Clinical Trials
Download it here!
  • 22 November 2013
  • 1568
Clinical Quality Forum, Beijing, China
Beat presenting at the 1st International Forum on the Quality of Clinical Research, Beijing, 22 - 23 October 2013
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  • 08 November 2013
  • 1496
Q&A on Design Space Verification
EMA and FDA publish new guidance on adhering to QbD principles:
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  • 06 November 2013
  • 1479
DIA Clinical Forum Dublin 2013
Peter Schiemann presented at the Clinical Forum in October 2013 about "A holistic Approach to Monitoring Clinical Trials". Download presentation here:
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  • 12 October 2013
  • 1671
Pharma Compliance Europe 2013
Wolfgang Beck was invited to speak at Pharma Compliance Europe 2013 about 'Service Honoraria at Fair Market Value'.
View the slides (pdf)
  • 10 October 2013
  • 1540
"A Roadmap For Sharing Clinical Trial Data"
Widler & Schiemann AG invited to participate and represent ABPI at the EFPIA/PhRMA event on "A Roadmap For Sharing Clinical Trial Data"!
Conference Report Conference Website
  • 10 October 2013
  • 1746
EFGCP, ACRES, EORTC and UCL organize a hands-on workshop
EFGCP, ACRES, EORTC and UCL organize a hands-on workshop on how to implement a risk based approach to managing quality in clinical trials
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  • 24 September 2013
  • 1719
Swiss government approved the new ordinance regarding the Swiss clinical research law
Beat Widler was invited by the Federal Office of Public Health (BAG) to provide a critical assessment of the new ordinance. Read the article here (german):
  • 04 September 2013
  • 1489
WSQMS create Clinical Trials Disclosure Tool for ABPI
WSQMS create Clinical Trials Disclosure Tool for ABPI (The Association of the British Pharmaceutical Industry). Visit this website for further information.
Further Publication#1Further Publication#2
  • 04 September 2013
  • 1623
Article about Quality Risk Management in RAPS Journal
WSQMS publish Article about Quality Risk Management in RAPS (Regulatory Affairs Professionals Society) Journal. Download article here:
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  • 30 July 2013
  • 1479
Article in EFGCP news by Beat Widler
You can find all new information from EFGCP and an article by Beat Widler in their summer report which you can find at their website or in this pdf for download:
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  • 01 April 2013
  • 3976
New Website

We are glad to welcome you on our new website, designed and implemented by 3K-Webdesign

  • 01 April 2013
  • 1467
Evaluation Results of our Webinar

Our recent webinar was a success. We are very proud to present the positive feedback of our clients. Click the button below to download the Evaluation.

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  • 18 March 2013
  • 5545
You can subscribe to the WSQMS Newsletter here!


Quality by Design

Our extensive track record and our close collaboration with regulators positions us uniquely to support clients in QbD projects with the latest development in methodologies and regulations.

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Quality Risk Management

As recognized experts in QRM we provide leading edge knowledge and support to clients developing and implementing a QRM approach.

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Risk-based Monitoring & Study Management

With the QbD and QRM methodologies we are in a unique position to help you design your new approach to a targeted and centralized monitoring and study management approach.

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SOP Management and Re-engineering

We have developed and successfully deployed a new approach to SOP management. Structured Content Management (SCM) allows tailoring the content of an SOP to the exact needs of each user group. With this we have created a whole set of clinical development SOPs that can easily be deployed in your company.

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Quality Strategy, Quality Policy & Quality Manuals

Many years of experience with large and small organizations developing Quality Strategies and key Quality documentation such as Quality Policy and Manual tailored to the customers specific needs.

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Design & Implementation of a Quality Management System

We have worked with large and small organizations and helped them develop and deploy a fit-for-purpose QMS. Their experience has allowed them to detect early obstacles or even resistance and to propose the right change management steps.

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GCP, Quality Risk Management & Quality Methodology Training

We are proud to be able to offer you tailored training courses as an in-house training for your staff either as refresher training or for newcomers.

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Service Provider & Vendor Qualification and Assessment

We have extensive experience in qualifying vendors and designing processes ranging from pre-contract assessments (risk based) to in process audits and quality risk assessments.

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GCP Issue Management

We have combined more than 35 years of experience in the GCP field and are viewed by many of our peers in the industry as thought-leaders in compliance matters and issues.

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Independent QA Support & Services

We have a demonstrated track record of successful implementations of QA plans and strategies as well as CAPA (Corrective and Preventive Action) programs and QA infrastructure and organizations.

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Inspection Readiness Support

We have developed and implemented processes to make organizations inspection ready. A toolkit has been developed to assist teams and functions to reach an inspection ready state.

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Quality Management of Pharmacovigilance Processes

We have developed a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or of spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need.

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Corporate Compliance

With our experience we are best positioned to define the systems’ requirements, perform a risk analysis and define and rollout of processes for health care compliance.

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Regulatory Intelligence Clinical Quality & Risk Management

Through our network, we are uniquely placed to learn early of planned changes that may impact your operations and even more important we are able to put these in the right legal and regulatory context to guide you to make the right process and organizational changes or to confidently refuse any change.

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