At INC Research, we continue to manage the longest running pregnancy registry. That’s why we were invited by the FDA to present on pregnancy registry best practices and to participate as a panel expert at their forum on this topic.
About Pregnancy Registries
Our dedicated group has experience across registry designs, products, diseases, and outcomes follow up.
We are known for our pregnancy registry expertise and leadership in this unique niche. Our teams have overcome many challenges from open-enrollment, integrating data from multiple healthcare providers, and complex subject-specific exposure assessments. Our registry best practices also extend to product and disease registries, where we have implemented several multi-national and multi-sponsor projects.
We have a long history of excellent interactions and negotiations with the Food and Drug Administration (FDA) on behalf of our Sponsors. Recognized as a leader in the industry, INC Research was the only CRO invited by the FDA to present on pregnancy registry best practice and participate as a panel expert at their forum, Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-approval Setting (May 28-29, 2014). INC Research provides efficient, scientifically rigorous registry programs that conform to FDA standards for conducting registry studies. In addition to the 2014 FDA forum, INC Research has worked directly and extensively with the FDA since 2002 in developing and refining their guidance document on pregnancy exposure registries. Our interaction with the FDA has not been limited to input on guidance documents, but also encompasses collaborative negotiation with sponsors and the FDA around pregnancy exposure registry design and reporting issues. INC Research is well positioned to leverage this tremendous experience in registry design, reporting, and FDA guidance to meet our sponsor needs.
As an industry leader in conducting pregnancy registries, INC Research Late Phase understands the unique challenges and benefits of conducting a registry as well as the fact that there is no one size fits all model. Because of our unparalleled experience in this area, our group prides itself on working with our sponsors to understand the unique nature and scientific merits of each registry that we conduct. We have consistently shown the ability to adapt and customize our processes with regards to our registries to fit the needs of each of our customers and address the distinctive challenges that can occur.
While each registry is different, our experience in this area has allowed us to create innovative solutions to many of the consistent challenges and obstacles our sponsors face.
Our Active Registries
Registries are an essential part of Late Phase identity and service offerings. The following represent a sampling of our active registries approved for patients, health care providers, and research professionals:
- Antiretroviral Pregnancy Registry (APR)
- Ribavirin Pregnancy Registry
- Savella Pregnancy Registry
- CIMZIA® Pregnancy Follow-up Study
- Cymbalta® Pregnancy Registry
- The MotHER Pregnancy Registry
Antiretroviral Pregnancy Registry (APR)
The Antiretroviral Pregnancy Registry (APR), established in 1989, is a voluntary, exposure-registration, observational, prospective study designed to collect data on pregnancy outcomes following prenatal exposure to antiretroviral drugs. The Registry is a primary source for evaluating use of antiretrovirals in pregnancy and currently follows exposures to more than 40 brand drugs, along with generic versions.
Because the Registry is very careful to protect the patient's confidentiality, participation in the Registry is conducted through a healthcare provider rather than directly with the patient. The Registry does not collect or maintain patient identifiers such as name, initials, contact information, or date of birth to assure confidentiality. If you would like to learn more about the Registry, please visit www.APRegistry.com.
If you are a patient, and would like to be enrolled in the Registry, please ask your healthcare provider to contact the Registry by email at SM_APR@INCResearch.com or by phone at (U.S.) 1-800-258-4263.
If you are a healthcare provider, and would like additional information or to enroll a patient, please contact the Registry Coordinating Center by email at SM_APR@incresearch.com or by phone at (U.S.) 1-800-258-4263.
Ribavirin Pregnancy Registry
Savella Pregnancy Registry
The Savella Pregnancy Registry is an observational registry created to learn about pregnancy outcomes of women who have taken Savella any time during pregnancy. As there are no studies investigating the effect of Savella in pregnant women, Savella should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The information gathered in this Registry may supplement other sources of data to assist Health Care Providers and patients in weighing the benefits and risks of being exposed to Savella around the time of conception and during pregnancy. If you are pregnant and have received Savella, you may qualify to participate. The Pregnancy Registry seeks participants who:
- Have taken Savella any time during pregnancy
- Are pregnant now
- Are residents of the United States
- Are 18 years old or older
- Will allow us to contact your doctor and your baby's doctor for information
Women willing to enroll may contact the Registry directly by calling: (U.S.) 1-877-643-3010
CIMZIA® Pregnancy Follow-up Study
The CIMZIA® Pregnancy Follow-up Study is sponsored by UCB Biosciences, Inc. (UCB), and collects information on women who become pregnant while participating in a CIMZIA® (Certolizumab Pegol, CZP) study, or whose pregnancies otherwise were reported to UCB due to potential CZP exposure during pregnancy. Information is collected about the pregnancy, the patient’s disease status during pregnancy, and health information about the patient and the infant(s) for 18 months after the pregnancy ends.
Enrollment into the study is initiated after UCB securely provides the Study Coordinating Center (CC) with contact information of patients who have become pregnant while taking CIMIZIA®. After the CC receives contact information, the Study Associate contacts the patient to obtain their informed consent and completes the enrollment process.
If you are a patient who has become pregnant while participating in a CZP study or you have had a potential CZP exposure during pregnancy and would like to be enrolled in the Pregnancy Follow-up Study, please contact the Study CC by email at CimziaPregnancyFollowUp@incresearch.com or by phone at (U.S.) 1-844-260-8170 (toll-free in the US) or at 919-745-2793. A Study Associate will assist in establishing your eligibility to participate in the study, and submit your information to UCB for enrollment.
If you are a healthcare provider, and would like additional information or to enroll a patient, please contact the Study CC by email at CimziaPregnancyFollowUp@incresearch.com or by phone (U.S.) 1-844-260-8170 (toll-free in the US) or at 919-745-2793. A Study Associate will assist in establishing your patient’s eligibility to participate in the study, and submit her information to UCB for enrollment.
Cymbalta® Pregnancy Registry
Pregnant patients who have taken Cymbalta® at any time during pregnancy, and their health care providers, may contact The Cymbalta® Pregnancy Registry via:
- Phone: (U.S.) 1-866-814-6975
The MotHER Pregnancy Registry
The MotHER Pregnancy Registry is a U.S.-based, prospective, observational cohort study in women with breast cancer treated with Herceptin®, PERJETA® in combination with Herceptin, or KADCYLA® during pregnancy or within 7 months prior to conception.
- Phone: (U.S.) 1-800-690-6720
- Email: pregnancyregistries@INCResearch.com
Our Global Registry Model
INC Research Late Phase has a large footprint in global registries and we have employed several global models with great success. Many of our registries have used the National Coordinator model to achieve results. Under this registry design, the INC Research Coordinating Center serves as the global management body who oversees the day to day operations of the registry, data management, analysis, reporting, and facilitation of an advisory committee. Each country outside of the U.S. has their own national coordinator that is contributing data to the Global Registry. The responsibilities of the National Coordinator include the facilitation of patient enrollment, the collection of data from reporters and the transfer of data to the central registry coordinating center.
Additional responsibilities can include the management of country specific regulatory requirements and data protection considerations. Additionally, the Late Phase group utilizes dedicated international phone numbers and fax lines to facilitate data collection in countries outside of the U.S. on current and past registries.
Patient and Healthcare Provider Awareness
Targeted awareness is a key approach to increasing enrollment in a registry. INC Research Late Phase has proposed, designed and managed many different awareness strategies tailored to reach the target populations of our pregnancy registries. Some of these initiatives have included:
- Management of the design and distribution of study specific brochures, posters, pregnancy wheels and information sheets to pharmacies, clinics and targeted healthcare provider offices
- Presentations at global conferences
- Implementation and ongoing monitoring of internet search engine optimization tools
- Website design, including redesign of existing registry websites to make them more accessible through videos, questions and answers, and having enrollment and participant consent forms available for download
- Facebook and YouTube awareness options