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Archive for the ‘ Uncategorized ’ Category

Birth Control Product Gains FDA Approval

Monday, June 1st, 2020

Exciting news!  A birth control product for use “in-the-moment,” evaluated by study participants at Coastal Connecticut Research, has gained FDA approval.  Thank you to our volunteers for participating in this women’s healthcare research study.

U.S. FDA Approves Evofem Biosciences

Phexxi TM (lactic acid, citric acid and potassium bitartrate),
the First and Only Non-Hormonal Prescription Gel for the Prevention of Pregnancy
A New Class of Female-Controlled Birth Control for Use In-The-Moment

SAN DIEGO, May 22, 2020 — Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S.
Food and Drug Administration (FDA) has approved Phexxi  TM (lactic acid, citric acid and potassium
bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an
on-demand method of contraception.

Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain
vaginal pH within the normal range of 3.5 to 4.5 an acidic environment that is inhospitable to sperm.
There have been a limited number of advances in birth control over the last two decades.

As the first vaginal pH regulator with a unique mechanism of action, the Company is working to have
Phexxi covered under the Affordable Care Act (ACA). The ACA mandates that private health plans provide
coverage with no out-of-pocket costs for one treatment per class in each of the classes identified by the
FDA for women in its Birth Control Guide.

Evofem is committed to ensuring access to Phexxi for all women seeking non-hormonal contraception,
including for women who are not covered by government or private health plans, and will provide a
financial assistance program to enable access for eligible women.

Covid-19 PEP Study

Saturday, May 9th, 2020

A groundbreaking effort seeking volunteers from states including Connecticut is being announced. The PEP (post-exposure prophylaxis) Study is seeking to evaluate the effectiveness of a treatment for people exposed to Covid-19. Scientists are seeking a preventative treatment.

COVID-19 PEP Study

Celebrating Nurses!

Thursday, May 7th, 2020

It’s National Nurses Week!  Where would we be without our nurses?  Thank you Diane Palmer, RN and Kelley Sanok, RN, for providing the highest quality care to all of our study patients.  Thank you for all of the behind-the-scenes work you do in the very detailed and involved field of clinical research.  You ladies are rock stars!  And, a special thank you to all those on the front lines during the Covid-19 pandemic.  Your selflessness is amazing.  Thank you!

 

 

 

What We Do is Essential!

Monday, March 23rd, 2020

We are proud to let you know what we do at Coastal Connecticut Research is considered essential by our state and federal government.  Providing exceptional study-related care to our patients, monitoring their health while they participate in a study, and educating potential participants about future studies and the importance of research is part of our daily operations.

We understand these are difficult times for our nation and for individuals as each of us responds to the Coronavirus crisis in different ways.  While we cannot control what is happening around us, we can control our reaction to what is happening around us and respond appropriately.  Some of you may be working from home, some of you who at a higher risk may be remaining at home, and all of us are urged to practice social distancing.  We have appropriate procedures in place to assure the health and safety of our study participants at this time in accordance to regulations being set forth.

So, if you are feeling anxious or cooped up, maybe it’s time to get out in the backyard, go for that long walk you could not get to during your regular 8-hour day, or even better, reconnect with an old friend through email or the telephone.  We can assure you when life returns to “normal,” we will still continue to be here for you.  In addition, if you are interested in a study, please know you can participate in a prescreening questionnaire over the telephone by calling (860)443-4567.  We are proud of the work we do and thankful for our study volunteers!

Coronavirus Statement – March 16, 2020

Monday, March 16th, 2020

At Coastal Connecticut Research our goal is to keep our study patients safe and healthy.  With the current concerns in place over social distancing and the Coronavirus, please keep in mind patient health and safety has always been our top priority.  In order to address national and global concerns in halting the spread of the Coronavirus, we will do the following:

  • We will continue to clean and sanitize all office and medical equipment prior to and following each patient visit
  • We will be limiting the number of patients we see during the course of the day as our country as a whole responds to requests for social distancing by the CDC.
  • We will assess the overall condition of our study patients upon each visit to our site by monitoring vital signs and general health while continuing to follow the protocol for each of our research studies.
  • With this in mind, please consider our request to you. If you are scheduled for an office visit, we ask you call us the day before to assess your current condition.  Study patients who are scheduled and may be displaying signs of any fever, respiratory infection or possible virus please contact our site prior to your visit to reschedule in order to ensure the health and safety of our research team and study participants.

Please contact Coastal Connecticut Research at (860)443-4567 if you have any further questions.  We look forward to continue to provide the highest quality study-related care to our patients.

Dr. Robert M. Spitz

Medical Director

Coastal Connecticut Research

 

Spring into Research!

Thursday, March 12th, 2020

 

The daffodils are starting to bud, birds seem to be chirping just a little bit more, spring is right around the corner!  Our volunteers continue to do good things for others by participating in clinical trials.

Here at Coastal Connecticut Research we are excited to share with you some of what will be happening this spring.  We will continue to enroll eligible subjects for a various clinical research trials including studies evaluating investigational products for hot flashes and night sweats, mild cognitive impairment with Parkinson’s disease, Alzheimer’s, and migraines.  A birth control study is also on the horizon.  It’s going to be a busy spring.

Thanks as always to all those who come forward to participate in research.  Your time is truly valued and we appreciate the fact your actions will ultimately help others as new treatments are developed.

Those who are curious about research are welcome to contact us to learn more.  Call today!  (860)443-4567.

Local Migraine Clinical Trial

Monday, February 3rd, 2020

Migraines aren’t all in your head!  12 percent of the population suffers with migraine headaches. Are you among them?  Sensitivity to lights, sounds, smells, nausea, pain, and the inability for some to focus at work.

Coastal Connecticut Research in New London is proud to be involved in migraine research. Questions about what’s happening in migraine research? We’d love to share with you what we do here. Call (860)443-4567.

A New Year

Monday, December 30th, 2019

2020. A new year is upon us.  It’s a time for people to make and ideally keep, resolutions.

Do you resolve to help others?  Did you know participating in research can help countless people through the development of new treatments for chronic conditions or diseases?

Coastal Connecticut Research has been conducting clinical research trials for two decades.  With your help, we can continue to make advancements in medicine by evaluating study products, devices and in some cases, developing new ways of testing.

So, this year when you decide you want to do something meaningful, please consider becoming a research volunteer!

Happy Holidays!

Thursday, December 19th, 2019

Are you decking the halls with boughs of holly?  Here at CCRstudies in New London, we would like to thank our valued study volunteers for their participation in clinical research this past year.

With 2020 in mind, we hope as you enter the new year you might consider participating in clinical research.  Many people resolve to be more giving, and often assume this involves writing a check to support a local charity or cause.  While this is a wonderful and worthy way to give back, have you ever thought of donating your time to others by participating in research?  It is a wonderful way to pay it forward.

The CCRstudies team had the good fortune of spending part of the busy month on December in bustling NYC.  We took in a show at Radio City Music Hall, met a real, live Rockette, and enjoyed the sights and sounds of the city.

Thank you again to all those medical heroes who come forward to participate in clinical research trials. We wish you a very happy holiday season!

Mrs. Judy Spitz, Dr. Robert Spitz, Kelley Sanok, RN, Mrs. Claus, MaryLou Gannotti, Diane Palmer, RN and Renee Cooper

 

Migraine Research

Thursday, December 5th, 2019

It was recently announced the FDA approved a medication to treat an acute migraine.  Did you know research is currently underway evaluating study treatments to potentially prevent a migraine from even happening?

Migraine headaches affect up to 12 percent of the population.  The majority of migraine sufferers are female.  When a migraine strikes, people often find themselves nauseous, sensitive to lights and sounds, and in tremendous pain.  Many have found past treatments have failed.  What is a migraine sufferer to do?

Migraines are often misunderstood and not everyone realizes just how incapacitating the condition can be.

Coastal Connecticut Research in New London has been involved in migraine research with study volunteers.  People who suffer from chronic migraines and wish to learn more about research, migraine research and the role of a study volunteer are welcome to call to speak with a member of the CCRstudies team at (860)443-4567. You can also text keyword CCR to 74121 or sign up for future studies online at CCRstudies.com.