Study Start-Up

Align CRO specializes in providing early phase oncology clinical research services to emerging biotech companies. An organized process to start up your study is an important first step Align CRO can help you accomplish. Align CRO is equipped with experienced staff to prepare, edit, or critique a wide range of documents needed for a Sponsor’s initial study start up including, but not limited to the following:

• A Study Management Plan (SMP) to include a Monitoring Plan, Data Management Plan, and other applicable processes and procedures related to the conduct of the study

• Study protocol development

• Protocol amendments and administrative letters as needed

• Study manuals

• Enrollment forms

• Case report forms (CRFs) / Electronic Data Capture (EDC) Recruitment documents

• Informed consent form template

• Site contract and budget templates

• Presentations, questionnaires, and any other documents necessary to conduct site evaluation and initiation visits

• Essential documents, which include the 1572, financial disclosure forms, protocol signature pages, and etc.

Additionally, Align CRO is able to draft any documents needed for properly conducting the trial throughout its continuance. All documents and templates created will follow not only the appropriate Align SOPs and Sponsor SOPs, but also in accordance to the agreed upon Study Management Plan.