Recommendations

After a long and challenging process, we have now finally received FDA approval […]. Thanks to all at Factory who have been involved in the study and helped us get over the finish line! We realise we still have much to do to be successful in the US but this is a real milestone for the company
Sponsor feedback after FDA Approval, June 2017

Thank you! You addressed my comments beautifully. It is so nice to read material from folks who can actually write!
Sponsor feedback, May 2017

Great progress on the CER drafts! Thanks to everyone for your time and energy, much appreciated!
Sponsor feedback, May 2017

Thank you for all your efforts and hard work to achieve this milestone.
It is really appreciated.
Thank you!
Sponsor feedback, May 2017

It is always a pleasure to work with you!
Principal Investigator of investigator-initiated study, September 2016

The ladies are great, I wish I could clone them, so I could steal them away from you, but I think we are going to keep them busy in the next couple of months as we start up our study.
Sponsor feedback, May 2016

The details provided in the monitor visit reports are excellent. Thumbs up!
Auditor during FDA mock audit procedure, April 2016

Thank you for this excellent and hard work. I’m so glad you pushed hard on Monday which gave us a great launch pad to digest and finalize by tomorrow. This was a bit more than I expected, but I’m very happy with the result and glad we iterated so quickly
Sponsor feedback after finalization of Clinical Study Report, April 2016

CRA did a very good job presenting and responding to questions about the study process and documentation. PI made some very positive comments on the professionalism of our team.
Sponsor feedback after SIV, April 2016

It was an absolute privilege to work with you and your company, giving us all the support in times, when things have not been so easy. Now, our team has consolidated impressively and I am proud and happy, that our Research Center is now at its best what it has ever been. Therefor I really thank you for your flexible support during times of change.
Also, I must express my great happiness that we were able to have such a wonderful, beautiful and competent monitor for our study.
Thank you again , hoping to meet in the near future. Principal Investigator feedback after completion of the trial, >May 2014

I also have some news – I’m moving across to R&D as of this week. It’s been great working with you guys – truly impressive levels of knowledge and support, you’ve led us through some difficult times and we’ve always come out on top as a result – please pass on my sincere thanks to all of the team. Sponsor feedback after change of jobs, October 2013

Thank you for your fantastic support during our study, you feel like part of our team and we could not have done the job without you! It has genuinely been a pleasure to work with you!

But! I’m dealing with a CRO who has messed up another submission to so badly that I ended up having a conference call while I was running wedding errands at Target (by the way, it is super fun to be yelling “cervix” into the phone in a public place. I make friends everywhere I go). I am so frustrated with this CRO….every submission or question is always so complicated. Honestly? This CRO has been difficult for the last year and I am so disappointed in their organization. I tell you this because I want you to know how much I value your work. You are the gold standard and I want you know I appreciate your team very much. I can always trust that you and your team will resolve problems independently and also surface the actual important issues. Your team has never kept me up until 3am on my day off.

Just wanted to let you know what an amazing job the CRA is doing with this study. She’s played a significant role in our company achieving and in most cases beating our submission timelines for the 3 countries. I’m really pleased with her, she’s a very valuable asset to your company. Please pass on my thanks to the relevant people.

Just wanted to thank you you again for pulling together a great event! Your hard work was well worth it! We got the answers we needed and hopefully everyone has more of an appreciation of the importance of the pathology piece of the trial. Good job!

Our Company is grateful for the outstanding effort Factory has given to this trial. It has been a pleasure working with you and we will be in contact with Factory again