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 | The PSI monitoring team has always set the standard for excellence in performance on the <Non-Hodgkin's Lymphoma> study. Clinical Trial Manager | ||
| It truly is a pleasure working with PSI over the last 6 years. I honestly cannot say that I’m as fond of other CROs I’m working with…PSI truly exhibits the “partner” relationship and we know that we can be demanding at times however not surprisingly, we usually hear that PSI rises to the occasion and delivers as requested." Associate Director, Clinical Operations | ||
| | We have all been so impressed with the work that you and your colleagues at PSI have done on our study. To my mind, we have some of the most impressive results ever obtained in the treatment of opioid dependence. Our success would not have been possible without the expert study management you have provided." Vice President | ||
| We have a very positive opinion of PSI's performance in <study code> and I have made sure senior management are aware of this. We are very grateful for the excellent work you have done ensuring both speed and quality." Associate Director, Clinical Operations | ||
| I have found that PSI was a perfect choice for us as a collaborating partner." Director of Clinical Research | ||
| Excellent team work all around." Director Clinical Operations | ||
| ... It will be a great pleasure and privilege to cooperate with the PSI team again with a goal to achieve the most successful results in our pediatric study, based upon your past and current history of very productive collaboration with <name of sponsor>." Senior Project Manager | ||
| A timely delivery of our first major Milestone! Thank you all for making this possible. As always we can depend so much on your projections and expertise. Doing studies with the PSI team is so much fun, since you never have to worry." Clinical Project Manager | ||
| | I wanted to say thank you very much for all your efforts, help, support and co-ordination of the Investigator Meeting in Buenos Aires. It was very well organised as we had expected and we were delighted by the level of discussion and interaction we had with LA Investigators both in terms to the protocol and the phase I and II data." Head of EU Clinical Operations | ||
| I wanted to thank you for all of your efforts in allowing us to meet our projected enrollment for our multiple myeloma study. I am quite impressed with our on time enrollment and our management is impressed as well." Senior Director, Clinical Operations | ||
| I wanted to thank you all for your outstanding efforts in CRF retrieval and query resolution. The field team put a tremendous amount of energy into making sure that our CRF casebook submission deadline was met, and their efforts are certainly recognized here at <name of sponsor>. Additionally, the sites are doing a phenomenal job in turning query resolutions around quickly and I am very impressed! I appreciate your hard work and thank you sincerely for your management of this important process. Keep up the good work!" Senior Clinical Research Associate | ||
| It was wonderful working with PSI. No other CRO is as productive and professional. I hope I get the chance to work with you again." Chief Medical Officer | ||
| Congratulations! With the randomization of the <AML> patient from <name of site> earlier today, we met our goal of enrolling 110 patients by the end of 2008 and actually exceeded the timeline by 8 weeks, which is phenomenal and representative of the spirit and effort that each of you contribute. This was a stretch goal for our team; enrolling this number of patients in a year has never been attempted or accomplished by anyone at our company, although I know that PSI does it routinely. <name of sponsor> can’t help but reminisce today of our shaky sighs of acceptance when we were asked to meet this goal nearly one year ago. We both recognize that the key to this success was and remains the energy and commitment of the unified team, but especially of the PSI team members." Clinical Progam Manager | ||
| PSI is an excellent company. These people know their clients and their resources, anticipate problems and propose solutions before you even realize that you need them." CEO | ||
| I would like to congratulate you and your team for your outstanding achievement in motivating your sites to enroll ... contracted number of patients. This is a testimony to the dedication and motivation displayed by your team and the investigators. I would also like to add that I am appreciative of the close and mutually constructive relationship between the <name of sponsor> and PSI team which has enabled this achievement." Clinical Project Manager | ||
| I just wanted to let you know how very impressed I am with our PSI Study Team. Elena, Joanna, Dmitry, and Dan have been absolutely wonderful (in general, too) during our CRC study Kick Off meeting this week. They are friendly, collaborative, knowledgeable, and patient as well as very diligent about their work and their interactions with the rest of the study team. Thank you very much for working with <name of sponsor> on this study, we know that your team is integral to the success of our study." Associate Director, Clinical Operations | ||
| Concerning the randomized <hemophilia> study I was impressed with the professionalism of the PSI team Elena, Mikhail and Svetlana and how well they are working together. The way and speed of getting the study up and running was intriguing. Moreover I cannot underline enough the superb performance of Mikhail, who monitored for us the Russian sites and brought the sites to such a high GCP standard, that our auditor was highly impressed. Mikhail managed to train the site with our most complex protocol in such a way, that they were able to enroll patients on a weekly basis! The exact timing of logistics, the perfect way to follow the study procedures and the accurate and fast CRF completion with this high workload left us all astonished. Project Manager | ||
| Well, congrats! you managed to repeat business with us and it is good news for the <protocol number> program. I was thinking about PSI..... I work closely with PSI US, PSI Russia, PSI PL, and even PSI Romania - my colleagues on <study number> will have the opportunity to work with PSI Argentina ( I am so jealous !!!!). Clearly, PSI is now a Global CRO, however the greatest asset of PSI is to be "philosophically" a Local CRO which means intimate knowledge of the country, regulatory aspects, investigators etc........ So, here is the idea - Apply to PSI the marketing concept of HSBC From a sponsor point of view - it works! " Clinical Development Manager | ||
| I too like working with PSI very much and think very fondly of all the study members I interact with. I know that the rest of the team here at <name of sponsor> enjoys the PSI interactions too. I have great admiration for the PSI team and the PSI method of work." Clinical Project Manager | ||
| Thanks very much Firdavs to you and your team. Your patience and understanding has been above and beyond expectations and <name of sponsor> wants you to know that PSI has done an outstanding job in every aspect." Senior Clinical Research Associate | ||
| | I was very impressed with you personally as well as with the quality of PSI work on <study drug>. Not often does it happen for me to be so impressed with a CRO." Vice President, Clinical Research & Regulatory | ||
| Congratulations for reaching the major milestone of randomization of 840 patients! This is a major accomplishment and was only possible due to the hard work and dedication that PSI has put into the study over the last 2 years. On behalf of the <name of sponsor> Team, I would like to thank you for helping to make this study a success." Director Clinical Development | ||
| | This is one of the most seamless partnerships between a sponsor and a CRO that I have ever seen." Vice President Global Clinical Operations | ||
| My general impression of the monitoring is positive regarding your study-specific knowledge, therapeutic area knowledge, site-interaction and general monitoring skills. I don't think <name of sponsor> could ask for better CRAs, so thank you all for your continued work." Project Director | ||
| On behalf of my team, please accept my appreciation for your most excellent investigator's meeting. I believe we have some wonderful momentum among the team! My very best to you, friend" Clinical Project Manager | ||
| We wanted to express our appreciation to the PSI CRAs and Project Assistants for the efforts to achieve the data lock. It has most certainly been an uphill climb, but the efforts of the individual team members have been extraordinary. The commitment to the project and to quality work is commendable, and we are grateful for their perseverance." Director Clinical Operations | ||
| I want to express my appreciation of [Project Manager] (and her team's) excellent work on this project. Deliverables are consistently produced within the expected timeframe and of excellent quality. <PM's> initiative in addressing issues early on is also much appreciated. With so many demands on my time, PSI's excellent work allows me to focus my attention on other study-related matters. It's a pleasure to work with such a fine team." Project Director | ||
| I just wanted to follow up on our close-out visit to Site <site#> performed on 21-March-07. The visit was excellent and went well according to all applicable PSI/<name of sponsor> SOPs and GCP requirements. As always, I had no queries or doubts on the high level of professionalism and study conduct by PSI team members. Everything was in place and in great order and the site was closed appropriately. Thank you again for all your hard work done on this trial! Best wishes to everyone, and I am looking forward to seeing all of you again." Project Manager | ||
| I want to say how wonderful it has been to work with all of you at PSI. You are an amazing group of people and I am so grateful to have had the opportunity to work with you and to meet most of you in person." Clinical Project Manager | ||
| Thank you very much for a very professional <investigators> meeting. I have taken part in investigator meetings in some 10 countries and I had worries this time about the translations. These worries proved unfounded. I must say that this meeting was the best that I have taken part in. Most of all I appreciated the investigator involvement and the quality of the questions raised. Good Luck to all of you and congratulations to <name of sponsor>. We have a good team to rely on." Chief Medical Officer | ||
| I think that PSI is providing great service and very good data. I am very glad that we will continue to work with you on future studies. Manager, Clinical Data Management | ||
| As you know, today is my last day at <name of sponsor> and I would like to take the opportunity to tell you that you have been the best CRO project directors I have ever worked with. You always have stayed so positive, energetic, creative, and solution-oriented, regardless of the sometimes impossible question that you were asked by us. I will miss the contact with you very much. Senior Manager, Clinical Projects | ||
| I want to thank you for all you have done for me and the <study> team. It has been a great pleasure to work with you - "Old Reliable" is your nickname (although you are not so old!) You are such a good project manager - I always felt comfortable knowing that you were there, watching over the study and making sure that things were done correctly. We are very lucky to have you as our project manager. I suspect your career at PSI will advance rapidly, as well it should. You are very good! Thank you for being so patient, reliable, cheerful, and committed. I hope we can work together again. You will be the first person I call for any clinical studies I will do in Eastern Europe. And you have such a beautiful city! Thank you for showing it to me. Clinical Project Manager | ||
| Thank you so much for your prompt response. I met with our CEO and Senior VP this afternoon, and they are very excited about the prospect of conducting a trial, for the first time, in Eastern Europe. They're also excited that we will have an excellent CRO on board. Senior Manager | ||
| Although the final investigator meeting in St. Petersburg is not quite completed, I want to take a moment to compliment you and your PSI team on the exceptionally high quality of the arrangements and planning that have gone into this week. There have been some questions to presenters regarding the content of their presentations, and we have tried to clarify/revise the materials based on that feedback. But the execution of the meetings themselves has been flawless. Every detail was anticipated by PSI staff in advance, and every day has gone smoothly. I believe the investigators will agree entirely. Senior Vice President / Chief Medical Officer | ||
| I wanted to thank your team for their efficient handling of the FDA inspection, and of the audit which preceded it. Dasha and Victoria were very flexible in making arrangements, and they accommodated all the changes rapidly and willingly. Being met at the airport is reassuring, and I am grateful to both Victoria and Anastasia for giving up their own time to do this. Manager, CQA | ||
| It has been really a pleasure working with PSI during these months/year and I will recommend PSI to any people from some other companies who want to perform clinical trials in Eastern European countries and additionally with an excellent quality. In the future if I'm again responsible for another clinical trial to be done in that geographical area I will contact you." Europe, March 2004 | ||
| ... and we can confirm that from our side the opinion on the PSI team is always of admiration. I have recently recommended PSI to a person from another company, so it's not only 'words'. " Europe, March 2004 | ||
| We're happy to be working with such a high functioning organization and such terrific people. Thanks for all the facilitation. USA, February 2004 | ||
| I would like to thank you very much for your hospitality and for the excellent preparation of our visits to the Russian sites. We got a very positive impression about the study centers and investigators as well as your work with the sites. Besides, everything was running very smoothly with respect to organization and logistics. So, thank you once again for your tremendous help with this visit. We are looking forward to a very successful study." Director Oncology, Clinical Development Europe | ||
| I would like to thank you for the continued efforts of all the PSI staff who have contributed to the achievement of our project's enrollment target for this year. In particular, I would like to thank you both <Head of Operations and Project Manager> for your attention since I believe your personal involvement has been a key to the project's success to date. We recognize and truly appreciate the importance of PSI's contribution to our project as the majority of the patients have been enrolled in Russia and Ukraine. Vice-President, Development & Chief Medical Officer | ||
| First of all I would like to say that it is clearly the consensus here at <name of sponsor> that PSI has been providing exceptionally excellent services in support of the current studies. Based on my review of the current studies, I am personally impressed with the quality and the quantity of work that your group has produced throughout the study. I am very excited to have this opportunity to be part of such a capable and effective group of clinical research professionals. It is my hope that I can contribute in whatever ways necessary to the continued effective and efficient management of the operations of these studies. Clinical Trials Manager | ||
| My sincere congratulations with the outcome of the first FDA inspection at the site of Dr. <name of investigator>. No form 483 is a great outcome. I would like to acknowledge your CRUCIAL contribution in all of this, both in the execution of the study as well as the preparation of the inspection.
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| Thank you very much for your efforts in organizing the upcoming investigator's meeting in St. Petersburg. I am really looking forward to visiting your offices and meeting the people who have done such a wonderful job in the collection of regulatory documents and in all aspects of the <name of study> study. I also look forward to working with you in our upcoming <name of study> study. I can't tell you how great it is to work with a company that is so knowledgeable of the regulations and who understands our requirements so well." Manager, Regulatory Affairs | ||
| What I forgot to say (and probably most important) is how impressed <name of sponsor> is with PSI and the sites. Please know that <name of sponsor> is more than happy that PSI will certainly be taking part in future <name of sponsor> studies through <name of sponsor> and according to <name of sponsor> "the US could learn something from Russia". Clinical Project Manager | ||
| Thank you for your prompt response; <name of sponsor> pharmacovigilance department has always been impressed by the level of responsiveness of PSI and the Russian sites to our requests. Sites are very prompt with follow-up and the reports are thorough when received. I appreciate your assistance in achieving this level of quality." Pharmacovigilance Associate | ||
| I want to extend my congratulations to the <Study name> Team for a job well done!! All queries have been resolved!! Associate Director, Clinical Operations | ||
| Please pass this on to your colleagues if they haven't seen it already. The results are really better than we could have possibly wished for. We really could not have done this without you and your excellent team. We are extremely appreciative." Chief Medical Officer, Client Company | ||
| And my personal thanks to you and your team. Your professionalism and dedication to our project was outstanding. It is a pleasure to work with you and your team." Client Company | ||
| Thank you so much for the Newsletter. <Reference to the Newsletter of the PSI Group "PSI Times">. The format and content are exceptional. I especially liked the first article: "How Toxic are Clinical Delays for the Industry". I am extremely glad to be working with PSI. The quality and efficiencies of service that PSI has provided to <name of sponsor> has been exceptional. Keep up the good work!" Clinical Trials Manager, Client company |